Trial Outcomes & Findings for Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors (NCT NCT04628780)
NCT ID: NCT04628780
Last Updated: 2024-07-29
Results Overview
For the purpose of dose escalation, any of the following adverse events were classified as DLTs: Occur in the first cycle of treatment, or within 28 days after the start of the study treatment; and were at least possibly related to PF-07209960; A participant was classified as DLT evaluable if he/she experienced a DLT or if he/she otherwise in the absence of a DLT received 2 doses of the study intervention during Cycle 1 and had received all scheduled safety assessments during the DLT window. If a participant failed to meet these criteria, he/she might be replaced. Monitoring for DLTs occurred during Part 1.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
Cycle 1 (28 days)
Results posted on
2024-07-29
Participant Flow
The study were planned to have 2 parts: a single agent dose escalation (Part 1) followed by a dose expansion (Part 2). Due to the early termination of the study, Part 2 study was never initiated and the overall study consisted of only Part 1. The data displayed are from the Part 1 study which is the only 1 period of the study.
A total of 37 participants were enrolled and assigned to study treatment.
Participant milestones
| Measure |
PF-07209960 1 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
3
|
16
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
4
|
3
|
16
|
6
|
Reasons for withdrawal
| Measure |
PF-07209960 1 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Progressive disease
|
2
|
2
|
2
|
3
|
9
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
3
|
1
|
|
Overall Study
Global deterioration of health status
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Mean
|
67.0 Years
STANDARD_DEVIATION 14.49 • n=5 Participants
|
60.5 Years
STANDARD_DEVIATION 15.33 • n=7 Participants
|
60.8 Years
STANDARD_DEVIATION 7.41 • n=5 Participants
|
54.0 Years
STANDARD_DEVIATION 4.58 • n=4 Participants
|
56.6 Years
STANDARD_DEVIATION 11.14 • n=21 Participants
|
54.8 Years
STANDARD_DEVIATION 13.92 • n=8 Participants
|
58.1 Years
STANDARD_DEVIATION 11.65 • n=8 Participants
|
|
Age, Customized
18-44 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Age, Customized
45-64 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Age, Customized
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 days)Population: The DLT analysis set was a subset of the safety analysis set. A participant was classified as DLT-evaluable if he/she experienced a DLT or received 100% of the planned doses and had received all scheduled safety assessments during the DLT window.
For the purpose of dose escalation, any of the following adverse events were classified as DLTs: Occur in the first cycle of treatment, or within 28 days after the start of the study treatment; and were at least possibly related to PF-07209960; A participant was classified as DLT evaluable if he/she experienced a DLT or if he/she otherwise in the absence of a DLT received 2 doses of the study intervention during Cycle 1 and had received all scheduled safety assessments during the DLT window. If a participant failed to meet these criteria, he/she might be replaced. Monitoring for DLTs occurred during Part 1.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=2 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=10 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Adverse event (AE) was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with treatment-related TEAEs
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with all-causality TEAEs
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
AE was any untoward medical occurrence in a participant who received any study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment and up to 90 days after last dose or start day of new anti-cancer drug therapy minus 1 day, whichever occurred first. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. In this outcome measure, number of participants with Maximum Grade 3 or 4 TEAEs were reported.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Maximum Grade 3 or 4 TEAEs
Participants with Maximum Grade 3 or 4 TEAEs (all-causality)
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
11 Participants
|
5 Participants
|
|
Number of Participants With Maximum Grade 3 or 4 TEAEs
Participants with Maximum Grade 3 or 4 TEAEs (treatment-related)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
TEAEs were those events with onset dates occurring during the on-treatment period.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Leading to Death
Participants with all-causality TEAEs leading to death
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With TEAEs Leading to Death
Participants with treatment-related TEAEs leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment until a minimum of 90 days after the last dose of study intervention. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs). A serious TEAE was any untoward medical occurrence that at any dose resulted in any of following outcomes/considered to be an important medical event: death; life-threatening experience (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious TEAEs
Participants with all-causality serious TEAEs
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
13 Participants
|
5 Participants
|
|
Number of Participants With Serious TEAEs
Participants with treatment-related serious TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
Participants who had an AE record that indicated that the AE caused the participant to be discontinued from the study. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as time from first dose of any study treatment until a minimum of 90 days after the last dose of study intervention. Treatment-related AEs were those related to any study drug (ie, at least one of the study drugs).
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants Discontinued From Study Due to TEAEs
Participants discontinued from study due to all-causality TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Discontinued From Study Due to TEAEs
Participants discontinued from study due to treatment-related TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
Activated partial thromboplastin time prolonged
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
13 Participants
|
5 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
Anemia
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
15 Participants
|
6 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
Fibrinogen decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hemoglobin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
INR increased
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
Lymphocyte count decreased
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
16 Participants
|
6 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
Platelet count decreased
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
Leukocytosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
Lymphocyte count increased
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=1 During the On-Treatment Period
White blood cell decreased
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
The number of participants with newly occurring or worsening hematology abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
Activated partial thromboplastin time prolonged
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
Leukocytosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
Lymphocyte count increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
White blood cell decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
INR increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
Lymphocyte count decreased
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
16 Participants
|
6 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
Anemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
Fibrinogen decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Hematology Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hemoglobin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Aspartate aminotransferase increased
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Creatinine increased
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hypoalbuminemia
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
5 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hypocalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hypokalemia
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
12 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Alanine aminotransferase increased
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Alkaline phosphatase increased
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hypercalcemia
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hyperkalemia
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hypermagnesemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hypernatremia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hypoglycemia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hypomagnesemia
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=1 During the On-Treatment Period
Hyponatremia
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From start of the treatment until a minimum of 90 days after the last dose of study intervention (maximum up to 16.6 months)Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
The number of participants with newly occurring or worsening chemistry abnormalities during the on-treatment period were summarized by worst grade on-treatment. NCI-CTCAE criteria version 5.0 is used. As per NCI CTCAE toxicity grading v5.0, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hypercalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hyperkalemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hypermagnesemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hypernatremia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hypoalbuminemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hypoglycemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hyponatremia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Alkaline phosphatase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Creatinine increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hypocalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hypokalemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New or Worsening Chemistry Laboratory Test Results to Grade >=3 During the On-Treatment Period
Hypomagnesemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of the treatment until disease progression or discontinuation from study or death due to any cause, whichever occurred first (maximum up to 14.5 months)Population: Response evaluable set included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment.
Objective Response Rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. CR: Complete disappearance of all target and non-target lesions with the exception of nodal disease; all target and non-target nodes must decrease to normal size (short axis \<10 mm); all lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; all target lesions must be assessed. Non-target PR lesions must be non-progressive disease (PD), where PD is unequivocal progression of pre-existing lesions.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=11 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=5 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
SECONDARY outcome
Timeframe: on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)Population: Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with \>=1 post-treatment ADA result (N1).
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n1=Number of ADA evaluable participants with positive ADA at baseline but did not become boosted post-treatment; n2=Number of ADA-positive participants (treatment-induced or treatment-boosted).
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=14 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=5 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants by Antidrug Antibody (ADA) Categories
Evaluable participants with pre-existing antibody, n/N1
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants by Antidrug Antibody (ADA) Categories
Baseline-positive participants with non-boosted antibody response, n1/N1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants by Antidrug Antibody (ADA) Categories
Overall Incidence, n2/N1
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
5 Participants
|
|
Number of Participants by Antidrug Antibody (ADA) Categories
Treatment-induced
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants by Antidrug Antibody (ADA) Categories
Treatment-boosted
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)Population: Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with \>=1 post-treatment ADA result (N1).
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (Nab) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. n=Number of ADA evaluable participants with positive ADA at baseline; n2=Number of ADA-positive participants.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=2 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=13 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=5 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories
Evaluable participants with pre-existing antibody, n/N1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by ADA Against Endogenous IL-15 Wild-type Categories
Overall Incidence, n2/N1
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: on Day 1,15 and 22 of Cycle 1, on Day 1 of Cycles 2-9, and then on Day 1 of Cycles 12, 15, and at the end of treatment (EOT)Population: Immunogenicity analysis set includes all enrolled participants who receive at least one dose of study treatment and have at least one sample tested for ADA. Number of participants analyzed = Number of participants with \>=1 post-treatment NAb result (N1).
Immunogenicity blood samples were assayed for ADA using a validated assay. The sample analysis followed a tiered approach of screening, confirmation, and titer determination. Samples tested positive for ADA were further analyzed for neutralizing antibodies (NAb) using a validated assay. Baseline is defined as pre-dose measurement on Day 1. N1=Number of participants with ≥ 1 post-treatment NAb result; n=Number of NAb evaluable participants with positive NAb at baseline; n2=Number of NAb-positive participants (treatment induced).
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=14 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=5 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Number of Participants by Anti-IL-15 Wild Type NAb Categories
Evaluable participants with pre-existing antibody, n/N1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Anti-IL-15 Wild Type NAb Categories
Overall Incidence, n2/N1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline through up to 2 years or until disease progressionPopulation: The full analysis set included all enrolled participants.
TTP is defined as the time from start date of treatment to the date of the first documentation of PD or censoring. TTP is similar to PFS except that death is not treated as an event and is censored. Both new anti-cancer therapy given prior to PD and no PD by the end of follow-up are censoring events
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Time to Progression (TTP) in Participants With Progressive Disease Based on Investigator Assessment
|
3.7 Months
Interval 1.4 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
2.8 Months
Interval 2.7 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
3.8 Months
Interval 1.9 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
1.6 Months
Interval 1.5 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
1.8 Months
Interval 1.6 to 3.7
|
2.0 Months
Interval 0.9 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
SECONDARY outcome
Timeframe: Baseline through up to 2 years or until disease progressionPopulation: The full analysis set included all enrolled participants.
DOR is defined as the time from first documentation of CR or PR to date of first documentation of objective progression, or death due to any cause, or time of censoring, whichever occurred first.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=1 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=1 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Duration of Response (DOR) Based on Investigator Assessment in Participants With Confirmed Response
|
9.5 Months
Only 1 participant had DOR record
|
3 Months
Only 1 participant had DOR record
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through up to 2 years or until disease progressionPopulation: The full analysis set includes all enrolled participants.
PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause, or censoring, whichever occurred first. Both new anti-cancer therapy given prior to PD or death and no PD by the end of follow-up are censoring events.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants
|
2.8 Months
Interval 1.4 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
2.8 Months
Interval 2.7 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
3.8 Months
Interval 1.9 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
1.6 Months
Interval 1.5 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
1.8 Months
Interval 1.4 to 3.5
|
2.0 Months
Interval 0.9 to
Upper limit of 95% CI was not reached due to fewer number of participants with event.
|
SECONDARY outcome
Timeframe: From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 2 years approximately)Population: Response evaluable set included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment.
Disease control rate (DCR) is defined as the percentage of participants with a BOR of CR, PR, non-CR/non-PD or SD.
Outcome measures
| Measure |
PF-07209960 1 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=11 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=5 Participants
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Disease Control Based on Investigator Assessment
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
75.0 Percentage of Participants
Interval 19.4 to 99.4
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
45.5 Percentage of Participants
Interval 16.7 to 76.6
|
40.0 Percentage of Participants
Interval 5.3 to 85.3
|
Adverse Events
PF-07209960 1 mg SC
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
PF-07209960 3 mg SC
Serious events: 3 serious events
Other events: 2 other events
Deaths: 1 deaths
PF-07209960 10 mg SC
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
PF-07209960 15 mg SC
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
PF-07209960 20 mg SC
Serious events: 13 serious events
Other events: 16 other events
Deaths: 3 deaths
PF-07209960 30 mg SC
Serious events: 5 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PF-07209960 1 mg SC
n=4 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Vertigo
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Disease progression
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
43.8%
7/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
4/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
PF-07209960 1 mg SC
n=4 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 1 mg as a subcutaneous (SC) administration every 2 weeks (Q2W) for a maximum duration of 10.9 months.
|
PF-07209960 3 mg SC
n=4 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 3 mg as a SC administration Q2W for a maximum duration of 5.1 months.
|
PF-07209960 10 mg SC
n=4 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 10 mg as a SC administration Q2W for a maximum duration of 3.4 months.
|
PF-07209960 15 mg SC
n=3 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 15 mg as a SC administration Q2W for a maximum duration of 5.8 months.
|
PF-07209960 20 mg SC
n=16 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 20 mg as a SC administration Q2W for a maximum duration of 13.6 months.
|
PF-07209960 30 mg SC
n=6 participants at risk
Participants with advanced or metastatic solid tumors were treated with PF-07209960 30 mg as a SC administration Q2W for a maximum duration of 12.6 months.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
4/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Angina pectoris
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Adrenal insufficiency
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
43.8%
7/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
4/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chills
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Discomfort
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Early satiety
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
37.5%
6/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
3/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site erythema
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site pruritus
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site reaction
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
100.0%
3/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
31.2%
5/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
8/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Swelling face
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
31.2%
5/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Herpes zoster
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pyuria
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
4/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Stoma site reaction
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Interleukin level increased
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Liver function test increased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
3/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
3/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Renal failure
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
37.5%
6/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
4/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
18.8%
3/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal paraesthesia
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
66.7%
2/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
4/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
2/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
31.2%
5/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
1/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
2/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
1/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
1/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
2/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/4 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/3 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/16 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • AEs are reported based on the on-treatment period (from first dose to 90 days post-last dose or start of new anti-cancer therapy - 1 day) for a maximum duration of 16.6 months.
Same event may appear as both an AE and SAE. However, what is presented are distinct events. Safety set was evaluated. The safety analysis set included all participants who received at least 1 dose of study drug. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
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