Trial Outcomes & Findings for Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients (NCT NCT01995513)
NCT ID: NCT01995513
Last Updated: 2023-09-18
Results Overview
PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
509 participants
Primary outcome timeframe
From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (maximum up to 20.3 months)
Results posted on
2023-09-18
Participant Flow
Participants received enzalutamide in first open label treatment period. Participants in second open label treatment period could cross over to receive abiraterone and prednisone. In double blind period participants were randomized to receive treatment with enzalutamide or placebo, each in combination with abiraterone and prednisone.
Participant milestones
| Measure |
Enzalutamide 160 mg
Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
|
Enzalutamide 160 mg Crossing Over to Abiraterone 1000 mg+ Prednisone 10 mg
Participants who received (after switching from enzalutamide), in second open label period, abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
|
Enzalutamide 160 mg+ Abiraterone 1000 mg+ Prednisone 10mg
Participants with confirmed prostate-specific antigen (PSA) progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at a 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo + Abiraterone 1000 mg+ Prednisone 10 mg
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at a 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
|---|---|---|---|---|
|
Period 1: First Open Label Treatment
STARTED
|
509
|
0
|
0
|
0
|
|
Period 1: First Open Label Treatment
COMPLETED
|
264
|
0
|
0
|
0
|
|
Period 1: First Open Label Treatment
NOT COMPLETED
|
245
|
0
|
0
|
0
|
|
Period 1: Second Open Label Treatment
STARTED
|
0
|
13
|
0
|
0
|
|
Period 1: Second Open Label Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 1: Second Open Label Treatment
NOT COMPLETED
|
0
|
13
|
0
|
0
|
|
Period 2: Double Blind Treatment
STARTED
|
0
|
0
|
126
|
125
|
|
Period 2: Double Blind Treatment
Treated
|
0
|
0
|
125
|
124
|
|
Period 2: Double Blind Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2: Double Blind Treatment
NOT COMPLETED
|
0
|
0
|
126
|
125
|
Reasons for withdrawal
| Measure |
Enzalutamide 160 mg
Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
|
Enzalutamide 160 mg Crossing Over to Abiraterone 1000 mg+ Prednisone 10 mg
Participants who received (after switching from enzalutamide), in second open label period, abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
|
Enzalutamide 160 mg+ Abiraterone 1000 mg+ Prednisone 10mg
Participants with confirmed prostate-specific antigen (PSA) progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at a 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo + Abiraterone 1000 mg+ Prednisone 10 mg
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at a 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
|---|---|---|---|---|
|
Period 1: First Open Label Treatment
Other
|
34
|
0
|
0
|
0
|
|
Period 1: First Open Label Treatment
Death
|
14
|
0
|
0
|
0
|
|
Period 1: First Open Label Treatment
Adverse Event
|
40
|
0
|
0
|
0
|
|
Period 1: First Open Label Treatment
Failure to Achieve PSA response at Week 13
|
43
|
0
|
0
|
0
|
|
Period 1: First Open Label Treatment
Disease Progression
|
92
|
0
|
0
|
0
|
|
Period 1: First Open Label Treatment
Protocol Non-Compliance
|
2
|
0
|
0
|
0
|
|
Period 1: First Open Label Treatment
Withdrawal by Subject
|
20
|
0
|
0
|
0
|
|
Period 1: Second Open Label Treatment
Other
|
0
|
2
|
0
|
0
|
|
Period 1: Second Open Label Treatment
Disease Progression
|
0
|
11
|
0
|
0
|
|
Period 2: Double Blind Treatment
Death
|
0
|
0
|
0
|
1
|
|
Period 2: Double Blind Treatment
Other
|
0
|
0
|
3
|
3
|
|
Period 2: Double Blind Treatment
Disease Progression
|
0
|
0
|
104
|
107
|
|
Period 2: Double Blind Treatment
Adverse Event
|
0
|
0
|
14
|
5
|
|
Period 2: Double Blind Treatment
Withdrawal by Subject
|
0
|
0
|
5
|
8
|
|
Period 2: Double Blind Treatment
Protocol Non-Compliance
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Enzalutamide 160 mg
n=509 Participants
Participants received enzalutamide 160 mg as four 40 mg capsules, orally once daily until disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed-up until 30 days after last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first.
|
|---|---|
|
Age, Continuous
|
72.3 years
STANDARD_DEVIATION 8.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
509 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (maximum up to 20.3 months)Population: ITT population included all participants randomly assigned to study treatment.
PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.7 months
Interval 4.6 to 8.1
|
5.6 months
Interval 4.5 to 7.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)Population: ITT population included all participants randomly assigned to study treatment.
Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of \>=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Time to Prostate Specific Antigen (PSA) Progression
|
2.8 months
Interval 2.8 to 2.9
|
2.8 months
Interval 2.8 to 2.8
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)Population: Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure.
PSA response rate was defined as percentage of participants with \>=30% and \>=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=124 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=122 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Prostate Specific Antigen (PSA) Response Rate
>= 50%
|
0.8 percentage of participants
Interval 0.0 to 4.4
|
2.5 percentage of participants
Interval 0.5 to 7.0
|
—
|
—
|
|
Prostate Specific Antigen (PSA) Response Rate
>= 30%
|
2.4 percentage of participants
Interval 0.5 to 6.9
|
2.5 percentage of participants
Interval 0.5 to 7.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)Population: ITT population (with measurable disease at screening) included all participants randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.
Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to \<10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: \>= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=38 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=40 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
CR + PR
|
0.0 percentage of participants
Interval 0.0 to 9.25
|
5.0 percentage of participants
Interval 0.61 to 16.92
|
—
|
—
|
|
Objective Response Rate (ORR)
CR + PR + SD
|
68.4 percentage of participants
Interval 51.35 to 82.5
|
57.5 percentage of participants
Interval 40.89 to 72.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: ITT population included all participants randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.
Rate of pain progression was defined as percentage of participants with an increase of \>=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=58 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=59 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Rate of Pain Progression
|
36.2 percentage of participants
Interval 24.0 to 49.9
|
27.1 percentage of participants
Interval 16.4 to 40.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 monthsPopulation: ITT population included all participants randomly assigned to study treatment.
It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Time to First Use of New Antineoplastic Therapy for Prostate Cancer
|
10.3 months
Interval 8.7 to 12.1
|
8.6 months
Interval 7.4 to 11.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89Population: ITT population included all participants randomly assigned to study treatment.
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Baseline
|
116.4 units on a scale
Standard Deviation 20.10
|
119.0 units on a scale
Standard Deviation 19.08
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 9
|
-3.3 units on a scale
Standard Deviation 14.90
|
-2.2 units on a scale
Standard Deviation 13.90
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 13
|
-4.4 units on a scale
Standard Deviation 14.44
|
-0.5 units on a scale
Standard Deviation 13.02
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 17
|
-3.7 units on a scale
Standard Deviation 12.40
|
-2.3 units on a scale
Standard Deviation 13.90
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 21
|
-2.5 units on a scale
Standard Deviation 12.33
|
-2.7 units on a scale
Standard Deviation 13.57
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 25
|
-3.1 units on a scale
Standard Deviation 13.47
|
-2.1 units on a scale
Standard Deviation 10.87
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 29
|
-6.8 units on a scale
Standard Deviation 13.98
|
0.3 units on a scale
Standard Deviation 12.10
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 33
|
-5.9 units on a scale
Standard Deviation 15.35
|
-0.2 units on a scale
Standard Deviation 12.90
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 37
|
-6.1 units on a scale
Standard Deviation 14.25
|
0.9 units on a scale
Standard Deviation 12.57
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 41
|
-5.7 units on a scale
Standard Deviation 12.17
|
1.3 units on a scale
Standard Deviation 14.13
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 45
|
-6.0 units on a scale
Standard Deviation 9.56
|
-2.6 units on a scale
Standard Deviation 16.27
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 49
|
-4.2 units on a scale
Standard Deviation 11.36
|
1.8 units on a scale
Standard Deviation 10.74
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 53
|
-4.8 units on a scale
Standard Deviation 10.17
|
1.8 units on a scale
Standard Deviation 14.68
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 57 (n =17, 13)
|
-4.3 units on a scale
Standard Deviation 9.73
|
0.1 units on a scale
Standard Deviation 7.45
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 61
|
-5.5 units on a scale
Standard Deviation 10.63
|
0.6 units on a scale
Standard Deviation 12.94
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 65
|
-7.0 units on a scale
Standard Deviation 7.86
|
1.9 units on a scale
Standard Deviation 9.50
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 69
|
-3.5 units on a scale
Standard Deviation 11.37
|
4.4 units on a scale
Standard Deviation 13.29
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 73
|
-0.7 units on a scale
Standard Deviation 7.26
|
-35.0 units on a scale
Standard Deviation NA
As only 1 participant was analyzed at Week 73, standard deviation could not be calculated.
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 77
|
-4.0 units on a scale
Standard Deviation 9.81
|
6.5 units on a scale
Standard Deviation 30.41
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 81
|
10.8 units on a scale
Standard Deviation 9.24
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 85
|
-5.5 units on a scale
Standard Deviation 3.54
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Change at Week 89
|
-2.0 units on a scale
Standard Deviation NA
As only participant was analyzed at Week 89, standard deviation could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89Population: ITT population included all participants randomly assigned to study treatment.
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Baseline
|
22.1 units on a scale
Standard Deviation 5.80
|
22.4 units on a scale
Standard Deviation 4.84
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 9
|
-0.5 units on a scale
Standard Deviation 4.33
|
-0.8 units on a scale
Standard Deviation 4.13
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 13
|
-0.4 units on a scale
Standard Deviation 3.46
|
-0.4 units on a scale
Standard Deviation 3.86
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 17
|
-0.1 units on a scale
Standard Deviation 3.68
|
-0.6 units on a scale
Standard Deviation 4.64
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 21
|
-0.5 units on a scale
Standard Deviation 3.24
|
-1.2 units on a scale
Standard Deviation 5.75
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 25
|
0.1 units on a scale
Standard Deviation 2.79
|
-1.0 units on a scale
Standard Deviation 5.25
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 29
|
-0.1 units on a scale
Standard Deviation 3.20
|
-0.2 units on a scale
Standard Deviation 5.18
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 33
|
-0.2 units on a scale
Standard Deviation 3.21
|
0.0 units on a scale
Standard Deviation 4.95
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 37
|
-0.8 units on a scale
Standard Deviation 3.04
|
0.8 units on a scale
Standard Deviation 2.79
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 41
|
-1.4 units on a scale
Standard Deviation 3.75
|
-0.1 units on a scale
Standard Deviation 3.51
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 45
|
-0.9 units on a scale
Standard Deviation 3.36
|
-0.8 units on a scale
Standard Deviation 3.75
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 49
|
-0.6 units on a scale
Standard Deviation 2.88
|
0.0 units on a scale
Standard Deviation 2.65
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 53
|
-1.0 units on a scale
Standard Deviation 3.15
|
0.4 units on a scale
Standard Deviation 2.56
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 57
|
-2.0 units on a scale
Standard Deviation 3.06
|
0.2 units on a scale
Standard Deviation 1.29
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 61
|
-1.5 units on a scale
Standard Deviation 2.77
|
-0.2 units on a scale
Standard Deviation 1.80
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 65
|
-1.5 units on a scale
Standard Deviation 2.54
|
-0.5 units on a scale
Standard Deviation 0.96
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 69
|
-1.4 units on a scale
Standard Deviation 2.03
|
-0.5 units on a scale
Standard Deviation 0.96
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 73
|
-0.6 units on a scale
Standard Deviation 3.22
|
-1.0 units on a scale
Standard Deviation NA
As only 1 participant was analyzed at Week 73, standard deviation could not be calculated.
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 77
|
-0.9 units on a scale
Standard Deviation 3.41
|
-0.5 units on a scale
Standard Deviation 0.71
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 81
|
6.2 units on a scale
Standard Deviation 5.42
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 85
|
-1.0 units on a scale
Standard Deviation 1.41
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Change at Week 89
|
0.0 units on a scale
Standard Deviation NA
As only 1 participant was analyzed at Week 89, standard deviation could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89Population: ITT population included all participants randomly assigned to study treatment.
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Baseline
|
18.1 units on a scale
Standard Deviation 3.80
|
18.5 units on a scale
Standard Deviation 4.06
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 9
|
-0.1 units on a scale
Standard Deviation 2.81
|
0.1 units on a scale
Standard Deviation 3.40
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 13
|
-0.1 units on a scale
Standard Deviation 3.55
|
0.2 units on a scale
Standard Deviation 3.09
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 17
|
-0.2 units on a scale
Standard Deviation 3.44
|
0.4 units on a scale
Standard Deviation 2.88
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 21
|
0.3 units on a scale
Standard Deviation 3.48
|
0.1 units on a scale
Standard Deviation 3.36
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 25
|
0.3 units on a scale
Standard Deviation 2.58
|
0.3 units on a scale
Standard Deviation 3.33
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 29
|
-0.5 units on a scale
Standard Deviation 3.56
|
0.3 units on a scale
Standard Deviation 3.27
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 33
|
0.1 units on a scale
Standard Deviation 3.33
|
0.9 units on a scale
Standard Deviation 2.99
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 37
|
-0.7 units on a scale
Standard Deviation 4.04
|
0.9 units on a scale
Standard Deviation 2.49
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 41
|
0.1 units on a scale
Standard Deviation 2.99
|
1.4 units on a scale
Standard Deviation 2.60
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 45
|
-0.5 units on a scale
Standard Deviation 3.23
|
1.2 units on a scale
Standard Deviation 2.76
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 49
|
0.0 units on a scale
Standard Deviation 3.00
|
1.3 units on a scale
Standard Deviation 2.75
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 53
|
0.1 units on a scale
Standard Deviation 2.72
|
1.2 units on a scale
Standard Deviation 3.23
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 57
|
-0.4 units on a scale
Standard Deviation 2.32
|
1.6 units on a scale
Standard Deviation 2.53
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 61
|
-0.3 units on a scale
Standard Deviation 3.14
|
1.1 units on a scale
Standard Deviation 3.62
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 65
|
-0.9 units on a scale
Standard Deviation 3.57
|
2.9 units on a scale
Standard Deviation 2.54
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 69
|
-0.5 units on a scale
Standard Deviation 2.93
|
1.5 units on a scale
Standard Deviation 2.93
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 73
|
1.0 units on a scale
Standard Deviation 2.83
|
-5.0 units on a scale
Standard Deviation 5.66
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 77
|
0.1 units on a scale
Standard Deviation 2.67
|
2.0 units on a scale
Standard Deviation 2.83
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 81
|
1.5 units on a scale
Standard Deviation 3.54
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 85
|
-1.5 units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Change at Week 89
|
-3.0 units on a scale
Standard Deviation NA
As only 1 participant was analyzed at Week 89, standard deviation could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89Population: ITT population included all participants randomly assigned to study treatment.
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 13
|
-1.2 units on a scale
Standard Deviation 4.07
|
-0.4 units on a scale
Standard Deviation 4.54
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Baseline
|
20.2 units on a scale
Standard Deviation 5.54
|
20.3 units on a scale
Standard Deviation 5.84
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 9
|
-1.0 units on a scale
Standard Deviation 4.23
|
-0.7 units on a scale
Standard Deviation 4.62
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 17
|
-1.3 units on a scale
Standard Deviation 4.00
|
-0.5 units on a scale
Standard Deviation 4.11
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 21
|
-1.2 units on a scale
Standard Deviation 5.03
|
-0.7 units on a scale
Standard Deviation 4.03
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 25
|
-1.0 units on a scale
Standard Deviation 3.41
|
-0.3 units on a scale
Standard Deviation 4.41
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 29
|
-2.4 units on a scale
Standard Deviation 4.67
|
-0.2 units on a scale
Standard Deviation 4.38
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 33
|
-2.0 units on a scale
Standard Deviation 5.14
|
-0.7 units on a scale
Standard Deviation 4.49
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 37
|
-1.5 units on a scale
Standard Deviation 5.22
|
0.2 units on a scale
Standard Deviation 5.72
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 41
|
-2.1 units on a scale
Standard Deviation 4.44
|
0.8 units on a scale
Standard Deviation 5.74
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 45
|
-2.0 units on a scale
Standard Deviation 3.37
|
-0.3 units on a scale
Standard Deviation 6.28
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 49
|
-2.1 units on a scale
Standard Deviation 4.55
|
1.5 units on a scale
Standard Deviation 5.02
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 53
|
-1.6 units on a scale
Standard Deviation 4.67
|
1.3 units on a scale
Standard Deviation 4.92
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 57
|
-1.4 units on a scale
Standard Deviation 4.06
|
2.0 units on a scale
Standard Deviation 4.37
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 61
|
-0.8 units on a scale
Standard Deviation 3.34
|
2.9 units on a scale
Standard Deviation 5.56
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 65
|
-1.2 units on a scale
Standard Deviation 2.21
|
1.7 units on a scale
Standard Deviation 2.75
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 69
|
0.2 units on a scale
Standard Deviation 1.48
|
2.3 units on a scale
Standard Deviation 4.23
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 73
|
-0.6 units on a scale
Standard Deviation 3.02
|
4.0 units on a scale
Standard Deviation 12.73
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 77
|
-1.6 units on a scale
Standard Deviation 3.91
|
2.5 units on a scale
Standard Deviation 9.19
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 81
|
-1.5 units on a scale
Standard Deviation 7.78
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 85
|
-1.5 units on a scale
Standard Deviation 2.12
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change at Week 89
|
1.0 units on a scale
Standard Deviation NA
As only 1 participant was analyzed at Week 89, standard deviation could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89Population: ITT population included all participants randomly assigned to study treatment.
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Baseline
|
33.2 units on a scale
Standard Deviation 6.85
|
34.2 units on a scale
Standard Deviation 6.45
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 9
|
-0.7 units on a scale
Standard Deviation 5.97
|
-0.9 units on a scale
Standard Deviation 5.18
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 13
|
-1.9 units on a scale
Standard Deviation 5.91
|
-0.1 units on a scale
Standard Deviation 5.36
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 17
|
-1.0 units on a scale
Standard Deviation 5.36
|
-1.4 units on a scale
Standard Deviation 5.10
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 21
|
-0.4 units on a scale
Standard Deviation 5.13
|
-0.6 units on a scale
Standard Deviation 4.83
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 25
|
-0.8 units on a scale
Standard Deviation 6.93
|
-0.8 units on a scale
Standard Deviation 4.42
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 29
|
-1.3 units on a scale
Standard Deviation 5.75
|
-0.3 units on a scale
Standard Deviation 4.77
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 33
|
-1.4 units on a scale
Standard Deviation 5.16
|
-0.6 units on a scale
Standard Deviation 4.88
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 37
|
-1.5 units on a scale
Standard Deviation 4.88
|
-0.8 units on a scale
Standard Deviation 4.32
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 41
|
-1.0 units on a scale
Standard Deviation 5.13
|
-0.7 units on a scale
Standard Deviation 5.34
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 45
|
-0.8 units on a scale
Standard Deviation 4.88
|
-1.7 units on a scale
Standard Deviation 7.02
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 49
|
-0.8 units on a scale
Standard Deviation 4.26
|
-0.9 units on a scale
Standard Deviation 4.63
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 53
|
-1.1 units on a scale
Standard Deviation 3.65
|
-1.8 units on a scale
Standard Deviation 5.78
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 57
|
-0.5 units on a scale
Standard Deviation 3.67
|
-3.3 units on a scale
Standard Deviation 4.48
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 61
|
-2.1 units on a scale
Standard Deviation 4.29
|
-3.1 units on a scale
Standard Deviation 5.68
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 65
|
-2.0 units on a scale
Standard Deviation 4.05
|
-2.6 units on a scale
Standard Deviation 6.32
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 69
|
-1.5 units on a scale
Standard Deviation 3.30
|
1.1 units on a scale
Standard Deviation 5.79
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 73
|
-0.2 units on a scale
Standard Deviation 3.17
|
-6.4 units on a scale
Standard Deviation 9.32
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 77
|
-1.0 units on a scale
Standard Deviation 3.71
|
-1.5 units on a scale
Standard Deviation 13.44
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 81
|
3.1 units on a scale
Standard Deviation 1.22
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 85
|
-0.5 units on a scale
Standard Deviation 0.71
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Change at Week 89
|
0.0 units on a scale
Standard Deviation NA
As only 1 participant was analyzed at Week 89, standard deviation could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89Population: ITT population included all participants randomly assigned to study treatment.
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Baseline
|
22.9 units on a scale
Standard Deviation 4.50
|
23.6 units on a scale
Standard Deviation 4.42
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 9
|
-0.8 units on a scale
Standard Deviation 4.04
|
0.1 units on a scale
Standard Deviation 3.20
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 13
|
-1.0 units on a scale
Standard Deviation 4.11
|
0.0 units on a scale
Standard Deviation 2.63
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 17
|
-1.1 units on a scale
Standard Deviation 3.26
|
-0.3 units on a scale
Standard Deviation 2.97
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 21
|
-0.8 units on a scale
Standard Deviation 3.11
|
-0.8 units on a scale
Standard Deviation 4.48
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 25
|
-1.7 units on a scale
Standard Deviation 4.23
|
-0.4 units on a scale
Standard Deviation 2.90
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 29
|
-2.5 units on a scale
Standard Deviation 4.89
|
0.3 units on a scale
Standard Deviation 2.67
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 33
|
-2.5 units on a scale
Standard Deviation 5.37
|
0.1 units on a scale
Standard Deviation 3.18
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 37
|
-1.8 units on a scale
Standard Deviation 4.50
|
0.4 units on a scale
Standard Deviation 3.13
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 41
|
-1.5 units on a scale
Standard Deviation 3.94
|
0.4 units on a scale
Standard Deviation 2.80
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 45
|
-2.0 units on a scale
Standard Deviation 3.72
|
-0.4 units on a scale
Standard Deviation 3.59
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 49
|
-0.9 units on a scale
Standard Deviation 3.78
|
0.6 units on a scale
Standard Deviation 2.12
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 53
|
-0.2 units on a scale
Standard Deviation 3.78
|
0.7 units on a scale
Standard Deviation 2.85
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 57
|
-0.4 units on a scale
Standard Deviation 3.25
|
0.4 units on a scale
Standard Deviation 2.37
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 61
|
-0.8 units on a scale
Standard Deviation 3.11
|
0.4 units on a scale
Standard Deviation 2.32
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 65
|
-1.9 units on a scale
Standard Deviation 4.25
|
0.4 units on a scale
Standard Deviation 1.99
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 69
|
-0.3 units on a scale
Standard Deviation 4.08
|
-0.5 units on a scale
Standard Deviation 2.67
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 73
|
-0.3 units on a scale
Standard Deviation 2.05
|
-3.0 units on a scale
Standard Deviation 5.66
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 77
|
-0.7 units on a scale
Standard Deviation 2.81
|
4.0 units on a scale
Standard Deviation 4.24
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 81
|
1.5 units on a scale
Standard Deviation 2.12
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 85
|
-1.0 units on a scale
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Change at Week 89
|
0.0 units on a scale
Standard Deviation NA
As only 1 participant was analyzed at Week 89, standard deviation could not be calculated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization up to maximum of 18.4 monthsPopulation: Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment.
Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=126 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
|
4.6 months
Interval 3.7 to 6.5
|
6.4 months
Interval 5.5 to 13.9
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)Population: Safety population included all participants who received any amount of study drug.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=509 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=13 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=124 Participants
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
93.5 percentage of participants
|
100 percentage of participants
|
91.2 percentage of participants
|
92.7 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
32.0 percentage of participants
|
30.8 percentage of participants
|
37.6 percentage of participants
|
29.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)Population: Safety population included all participants who received any amount of study drug.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=509 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=13 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=124 Participants
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
Drug Discontinuation with Enzalutamide or Placebo
|
11.8 percentage of participants
|
—
|
23.2 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
Drug Discontinuation with Abiraterone
|
—
|
7.7 percentage of participants
|
23.2 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
Drug Discontinuation with Prednisone
|
—
|
7.7 percentage of participants
|
16.0 percentage of participants
|
12.1 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)Population: Safety population included all participants who received any amount of study drug.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=509 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=13 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=124 Participants
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Leading to Death
|
5.9 percentage of participants
|
0 percentage of participants
|
3.2 percentage of participants
|
2.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)Population: Safety population included all participants who received any amount of study drug. "Number Analyzed" signifies participants evaluable for the specified categories for respective arms.
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Outcome measures
| Measure |
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=509 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=13 Participants
Participants with confirmed PSA progression at Week 21 in open label period, received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in double blind treatment period, up to disease progression (as defined by radiographic imaging or unequivocal clinical progression or death on study), intolerable toxicity, or participant withdrawal, whichever occurred first. Participants were followed up for 16 weeks at 4-week interval after discontinuation of study drug for survival and subsequent antineoplastic therapy for prostate cancer.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=125 Participants
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo+Abiraterone 1000mg+ Prednisone 10mg
n=124 Participants
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs related to Enzalutamide or Placebo
|
66.6 percentage of participants
|
—
|
46.4 percentage of participants
|
36.3 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs related to Abiraterone
|
—
|
38.5 percentage of participants
|
54.4 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
TEAEs related to Prednisone
|
—
|
7.7 percentage of participants
|
36.0 percentage of participants
|
32.3 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs related to Enzalutamide or Placebo
|
4.1 percentage of participants
|
—
|
7.2 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs related to Abiraterone
|
—
|
0 percentage of participants
|
7.2 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs related to Prednisone
|
—
|
0 percentage of participants
|
2.4 percentage of participants
|
4.8 percentage of participants
|
Adverse Events
Enzalutamide 160 mg
Serious events: 163 serious events
Other events: 474 other events
Deaths: 32 deaths
Enzalutamide Crossing Over to Abiraterone + Prednisone
Serious events: 4 serious events
Other events: 13 other events
Deaths: 1 deaths
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Serious events: 47 serious events
Other events: 113 other events
Deaths: 14 deaths
Placebo + Abiraterone 1000 mg + Prednisone 10mg
Serious events: 37 serious events
Other events: 113 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Enzalutamide 160 mg
n=509 participants at risk
Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.
|
Enzalutamide Crossing Over to Abiraterone + Prednisone
n=13 participants at risk
Participants who received (after switching from enzalutamide) abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=125 participants at risk
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo + Abiraterone 1000 mg + Prednisone 10mg
n=124 participants at risk
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Angina pectoris
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Angina unstable
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Cardiac failure
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Coronary artery disease
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Palpitations
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Pericardial effusion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Exophthalmos
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Asthenia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Chest pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Death
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Disease progression
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Fatigue
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
General physical health deterioration
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Local swelling
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Malaise
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Multi-organ failure
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Oedema peripheral
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Pain
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Pyrexia
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Abscess limb
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Appendicitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Cellulitis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Device related infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Endocarditis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Enterococcal sepsis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Influenza
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Meningitis tuberculous
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Metapneumovirus infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Pneumonia
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Pulmonary sepsis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Sepsis
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Septic shock
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Skin infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Urosepsis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood bilirubin increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Liver function test abnormal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Weight decreased
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Dystrophic calcification
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Gout
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage 0
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma metastatic
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Brain oedema
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cerebellar infarction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dementia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dysarthria
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Loss of consciousness
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Nerve root compression
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Presyncope
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Spinal cord compression
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Stupor
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Syncope
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Confusional state
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Delirium
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Depression
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Calculus bladder
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Haematuria
|
2.2%
11/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Nephropathy
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Prerenal failure
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Renal failure acute
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urinary retention
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Aortic stenosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Arterial rupture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Arteriosclerosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Circulatory collapse
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Hypertension
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Hypotension
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Hypovolaemic shock
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Orthostatic hypotension
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
Other adverse events
| Measure |
Enzalutamide 160 mg
n=509 participants at risk
Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.
|
Enzalutamide Crossing Over to Abiraterone + Prednisone
n=13 participants at risk
Participants who received (after switching from enzalutamide) abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.
|
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
n=125 participants at risk
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
Placebo + Abiraterone 1000 mg + Prednisone 10mg
n=124 participants at risk
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
|
|---|---|---|---|---|
|
General disorders
Hypothermia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.3%
32/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
6.5%
8/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Angina pectoris
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Angina unstable
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Arrhythmia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Atrial flutter
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Bradycardia
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Bundle branch block right
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Cardiac failure
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Extrasystoles
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Mitral valve disease
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Palpitations
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Tachycardia
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
2.8%
14/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Endocrine disorders
Goitre
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Endocrine disorders
Hypothyroidism
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Endocrine disorders
Thyroid mass
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Amaurosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Cataract
|
2.6%
13/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Conjunctivitis
|
2.0%
10/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Diplopia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Dry eye
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Exophthalmos
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Eye disorder
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Eye irritation
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Eye pain
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Eye swelling
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Eyelid margin crusting
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Glaucoma
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Iritis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Lacrimation increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Macular fibrosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Night blindness
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Ocular icterus
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Photophobia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Retinal artery occlusion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Strabismus
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Trichiasis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Vision blurred
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Visual acuity reduced
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Visual impairment
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Vitreous floaters
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Eye disorders
Vitreous haemorrhage
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Abasia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Asthenia
|
5.1%
26/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Axillary pain
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Catheter site haemorrhage
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Chest discomfort
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Chest pain
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Chills
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Cyst
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Device failure
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Device leakage
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Device occlusion
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Discomfort
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Dysplasia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Face oedema
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Facial pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Fatigue
|
40.5%
206/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
16.0%
20/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
15.3%
19/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Feeling abnormal
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Feeling drunk
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Feeling hot
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Gait disturbance
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
General physical health deterioration
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Hunger
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Hyperpyrexia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Inflammation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Influenza like illness
|
1.8%
9/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Infusion site extravasation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Injection site swelling
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Irritability
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Local swelling
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Malaise
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Medical device complication
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Mucosal inflammation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Non-cardiac chest pain
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Oedema
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Oedema peripheral
|
10.0%
51/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
6.4%
8/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
14.5%
18/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Pain
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Performance status decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Pyrexia
|
2.2%
11/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
General disorders
Suprapubic pain
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
16/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
5.6%
7/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
6.5%
8/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.1%
21/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Anal fissure
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Apical granuloma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Breath odour
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Cheilitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Constipation
|
16.5%
84/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
17.6%
22/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
11.3%
14/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Dental caries
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
73/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.2%
9/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
12.1%
15/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Diverticulum
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
16/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Eructation
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Faecaloma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Faeces hard
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
12/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Food poisoning
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gastric mucosa erythema
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.6%
13/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gingival inflammation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Gingival pain
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Glossodynia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Haematochezia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Lip oedema
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Lip swelling
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Melaena
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Nausea
|
19.6%
100/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
18.4%
23/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
9.7%
12/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Odynophagia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Oral discharge
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Proctalgia
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Retching
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Toothache
|
2.4%
12/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
29/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
8.8%
11/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Jaundice
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Hepatobiliary disorders
Pneumobilia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Immune system disorders
Hypersensitivity
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Immune system disorders
Milk allergy
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Immune system disorders
Seasonal allergy
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Abdominal abscess
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Abscess
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Abscess neck
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Arthritis infective
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Bronchitis
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Bronchopneumonia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Catheter site infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Cellulitis
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Corona virus infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Cystitis
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Diverticulitis
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Ear infection
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Erysipelas
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Eye infection
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Eyelid infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Folliculitis
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Fungal skin infection
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Furuncle
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Gastric infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Genital candidiasis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Gingival infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Helicobacter infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Herpes zoster
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Herpes zoster oticus
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Infected dermal cyst
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Infection
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Infection parasitic
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Influenza
|
4.7%
24/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
6.4%
8/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Injection site infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Labyrinthitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Laryngitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Lip infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Localised infection
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Mediastinitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.9%
20/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Lung infection
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Nail infection
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
36/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
6.5%
8/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Onychomycosis
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Oral candidiasis
|
1.8%
9/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Oral herpes
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Otitis media
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Peritonitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Pharyngitis
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Pneumonia
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Rash pustular
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Respiratory tract infection
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Rhinitis
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Scrotal abscess
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Sialoadenitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Sinusitis
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Skin candida
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Skin infection
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Soft tissue infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Tooth infection
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
30/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.2%
9/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Urethritis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
34/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
8.0%
10/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
5.6%
7/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Urosepsis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Infections and infestations
Viral infection
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
51/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
15.4%
2/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
11.2%
14/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
8.1%
10/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Incision site hypoaesthesia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.8%
9/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
15.4%
2/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Wound
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
6.4%
8/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Bacterial test positive
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood albumin increased
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood bilirubin increased
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood calcium decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood calcium increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood cholesterol increased
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood creatinine increased
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood glucose increased
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood iron decreased
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood potassium decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood potassium increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood pressure increased
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood pressure orthostatic decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Blood urine present
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Cardiac murmur
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Cardioactive drug level increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Cystoscopy
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Ejection fraction decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Gamma-glutamyltransferase abnormal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Haematocrit decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Haemoglobin decreased
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Heart rate increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Heart rate irregular
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Heart sounds abnormal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Hepatic enzyme increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
International normalised ratio increased
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Liver function test abnormal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Lymph node palpable
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Lymphocyte count decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Norovirus test positive
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Respiratory rate increased
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Transaminases increased
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Troponin increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Urine output decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Vitamin B12 decreased
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Weight decreased
|
4.9%
25/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
Weight increased
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
White blood cell count decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Investigations
White blood cell count increased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.3%
83/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
15.4%
2/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
11.2%
14/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
8.9%
11/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Gout
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.0%
10/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
8.8%
11/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
5.6%
7/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.3%
78/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
15.4%
2/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
17.6%
22/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
12.9%
16/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.0%
112/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
20.8%
26/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
22.6%
28/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone fistula
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.1%
21/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.8%
14/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Inguinal mass
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
10/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
15.4%
2/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.3%
9/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.1%
21/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
15.4%
2/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
27/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
11.2%
14/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
5.6%
7/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.5%
38/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
10.4%
13/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.3%
9/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.7%
24/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
25/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
37/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
9.6%
12/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
5.6%
7/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Tendon calcification
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.4%
12/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign urinary tract neoplasm
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroidal haemangioma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Ageusia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Amnesia
|
1.8%
9/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Ataxia
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Balance disorder
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Burning sensation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cerebellar atrophy
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cerebral atrophy
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Cognitive disorder
|
2.2%
11/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dementia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Disturbance in attention
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dizziness
|
9.6%
49/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dizziness postural
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dysaesthesia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dysarthria
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dysgeusia
|
4.7%
24/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Dyskinesia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Facial paresis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Head discomfort
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Headache
|
9.8%
50/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Hemiparesis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Hyperreflexia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
12/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Hypoglossal nerve paralysis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Hypokinesia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Lethargy
|
7.3%
37/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Loss of consciousness
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Memory impairment
|
3.1%
16/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Migraine
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Neuralgia
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Paraesthesia
|
4.5%
23/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Parkinson's disease
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Parkinsonian gait
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Poor quality sleep
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Presyncope
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Radicular pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Restless legs syndrome
|
2.0%
10/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Sciatica
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Sensory disturbance
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Somnolence
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Syncope
|
1.2%
6/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Tongue paralysis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Tremor
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Abnormal dreams
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Agitation
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Anxiety
|
3.1%
16/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Apathy
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Bruxism
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Confusional state
|
2.0%
10/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Daydreaming
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Delirium
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Depressed mood
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Depression
|
2.4%
12/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Disorientation
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Emotional disorder
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Flat affect
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Hallucination
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Initial insomnia
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Insomnia
|
7.9%
40/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Mood altered
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Mood swings
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Nightmare
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Sleep disorder
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Psychiatric disorders
Stress
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Bladder spasm
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Calculus bladder
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Dysuria
|
2.4%
12/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Haematuria
|
3.9%
20/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
8.9%
11/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Incontinence
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Micturition urgency
|
1.4%
7/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Nocturia
|
3.5%
18/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Pollakiuria
|
2.6%
13/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Polyuria
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Prerenal failure
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Renal colic
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Renal failure
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Renal impairment
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Strangury
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urethral dilatation
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urethral pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urethritis noninfective
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urge incontinence
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.5%
18/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Breast pain
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Genital rash
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
2.2%
11/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
10/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Prostatic pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
30/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
5.6%
7/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.3%
9/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.9%
40/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.8%
6/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
4.0%
5/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.8%
9/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
10/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal disorder
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal erythema
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.79%
4/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Actinic prurigo
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
11/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.2%
11/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Nail growth abnormal
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Photodermatosis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
8/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
17/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
6.4%
8/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Sticky skin
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Social circumstances
Physical assault
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Cataract operation
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Dupuytren's contracture operation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Hip surgery
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Mole excision
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Nasal polypectomy
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Peripheral nerve decompression
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Pterygium operation
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Tendon sheath incision
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Surgical and medical procedures
Tooth extraction
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
1.6%
2/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Aortic aneurysm
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Flushing
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Haematoma
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Haemorrhage
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Hot flush
|
17.7%
90/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
7.7%
1/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
6.4%
8/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
2.4%
3/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Hypertension
|
10.2%
52/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
19.2%
24/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
8.9%
11/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Hypotension
|
1.8%
9/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
3.2%
4/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Lymphoedema
|
0.39%
2/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.81%
1/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Orthostatic hypotension
|
0.98%
5/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.80%
1/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Peripheral coldness
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Phlebitis
|
0.59%
3/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Phlebitis superficial
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
|
Vascular disorders
Thrombosis
|
0.20%
1/509 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/13 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/125 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
0.00%
0/124 • Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER