Trial Outcomes & Findings for Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC (NCT NCT03395197)
NCT ID: NCT03395197
Last Updated: 2025-12-30
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per Common Terminology Criteria for Adverse Events (CTCAE) version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
ACTIVE_NOT_RECRUITING
PHASE3
1054 participants
Post dose on Day 1 up to Day 66 in Part 1
2025-12-30
Participant Flow
As of the data cutoff for the primary completion date (PCD) on 16 Aug 2022 for Part 1 and Part 2 Cohort 1 and on 03 Oct 2022 for Part 2 Cohort 2, for overall study, 2896 participants were screened for participation in the C3441021 study. As of 03 Oct 2022, a total of 1054 participants were enrolled in this study.
As of 16 Aug 2022, 19 participants were enrolled in Part 1, 805 participants with metastatic castrate-resistant prostate cancer (mCRPC) unselected for DNA damage response (DDR) deficiencies were randomized in Part 2 Cohort 1. As of 03 Oct 2022, 169 DDR-deficient participants enrolled in Cohort 1 were combined with the 230 DDR-deficient participants enrolled in Cohort 2 such that 399 participants were included in the analysis for participants with DDR deficiencies.
Participant milestones
| Measure |
Part 1: Talazoparib 1 mg QD+Enzalutamide
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 0.5 mg QD+Enzalutamide
Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022).
|
Part 2 Cohort 1: Talazoparib+Enzalutamide (All-comer)
Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
Part 2 Cohort 1: Placebo+Enzalutamide (All-comer)
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 2 Cohort 2: Talazoparib+Enzalutamide (DDR-deficient)
Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022).
|
Part 2 Cohort 2: Placebo+Enzalutamide (DDR-deficient)
Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022).
|
|---|---|---|---|---|---|---|
|
Study Recruitment
STARTED
|
13
|
6
|
402
|
403
|
115
|
115
|
|
Study Recruitment
COMPLETED
|
13
|
6
|
402
|
403
|
115
|
115
|
|
Study Recruitment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
STARTED
|
13
|
6
|
402
|
403
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
NOT COMPLETED
|
13
|
6
|
402
|
403
|
0
|
0
|
|
Analysis for DDR-Deficient Participants
STARTED
|
0
|
0
|
0
|
0
|
200
|
199
|
|
Analysis for DDR-Deficient Participants
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Analysis for DDR-Deficient Participants
NOT COMPLETED
|
0
|
0
|
0
|
0
|
200
|
199
|
Reasons for withdrawal
| Measure |
Part 1: Talazoparib 1 mg QD+Enzalutamide
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 0.5 mg QD+Enzalutamide
Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022).
|
Part 2 Cohort 1: Talazoparib+Enzalutamide (All-comer)
Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
Part 2 Cohort 1: Placebo+Enzalutamide (All-comer)
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 2 Cohort 2: Talazoparib+Enzalutamide (DDR-deficient)
Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022).
|
Part 2 Cohort 2: Placebo+Enzalutamide (DDR-deficient)
Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022).
|
|---|---|---|---|---|---|---|
|
Analysis for Part 1 and Part 2 Cohort 1
Withdrawal by Subject
|
0
|
1
|
29
|
30
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
Global Deterioration Of Health Status
|
1
|
0
|
44
|
46
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
Other
|
1
|
1
|
4
|
5
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
Ongoing
|
1
|
0
|
152
|
120
|
0
|
0
|
|
Analysis for DDR-Deficient Participants
Death
|
0
|
0
|
0
|
0
|
1
|
4
|
|
Analysis for DDR-Deficient Participants
No longer clinically benefiting
|
0
|
0
|
0
|
0
|
5
|
8
|
|
Analysis for DDR-Deficient Participants
Not treated with talazoparib
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Analysis for DDR-Deficient Participants
Adverse Event
|
0
|
0
|
0
|
0
|
19
|
11
|
|
Analysis for DDR-Deficient Participants
Progressive Disease
|
0
|
0
|
0
|
0
|
39
|
60
|
|
Analysis for DDR-Deficient Participants
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
11
|
13
|
|
Analysis for Part 1 and Part 2 Cohort 1
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
Death
|
0
|
0
|
8
|
10
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
No longer meets eligibility ceriteria
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
No longer clinically benefiting
|
0
|
0
|
14
|
21
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
Not treated with talazoparib
|
0
|
0
|
5
|
3
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
Adverse Event
|
9
|
3
|
69
|
43
|
0
|
0
|
|
Analysis for Part 1 and Part 2 Cohort 1
Progressive Disease
|
1
|
1
|
76
|
124
|
0
|
0
|
|
Analysis for DDR-Deficient Participants
Global Deterioration Of Health Status
|
0
|
0
|
0
|
0
|
24
|
40
|
|
Analysis for DDR-Deficient Participants
Other
|
0
|
0
|
0
|
0
|
3
|
3
|
|
Analysis for DDR-Deficient Participants
Ongoing
|
0
|
0
|
0
|
0
|
95
|
60
|
Baseline Characteristics
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
Baseline characteristics by cohort
| Measure |
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=13 Participants
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 0.5 mg QD+Enzalutamide
n=6 Participants
Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022).
|
Part 2 Cohort 1: Talazoparib+Enzalutamide (All-comer)
n=402 Participants
Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
Part 2 Cohort 1: Placebo+Enzalutamide (All-comer)
n=403 Participants
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 2 Cohort 2: Talazoparib+Enzalutamide (DDR-deficient)
n=115 Participants
Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022).
|
Part 2 Cohort 2: Placebo+Enzalutamide (DDR-deficient)
n=115 Participants
Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022).
|
Total
n=1054 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
1 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
79 Participants
n=167 Participants
|
94 Participants
n=164 Participants
|
25 Participants
n=671 Participants
|
26 Participants
n=77 Participants
|
227 Participants
n=4 Participants
|
|
Age, Customized
65-<75 years
|
8 Participants
n=174 Participants
|
4 Participants
n=166 Participants
|
188 Participants
n=167 Participants
|
175 Participants
n=164 Participants
|
53 Participants
n=671 Participants
|
55 Participants
n=77 Participants
|
483 Participants
n=4 Participants
|
|
Age, Customized
>=75 years
|
4 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
135 Participants
n=167 Participants
|
134 Participants
n=164 Participants
|
37 Participants
n=671 Participants
|
34 Participants
n=77 Participants
|
344 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=174 Participants
|
6 Participants
n=166 Participants
|
402 Participants
n=167 Participants
|
403 Participants
n=164 Participants
|
115 Participants
n=671 Participants
|
115 Participants
n=77 Participants
|
1054 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=174 Participants
|
6 Participants
n=166 Participants
|
243 Participants
n=167 Participants
|
255 Participants
n=164 Participants
|
88 Participants
n=671 Participants
|
90 Participants
n=77 Participants
|
694 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
11 Participants
n=167 Participants
|
5 Participants
n=164 Participants
|
4 Participants
n=671 Participants
|
3 Participants
n=77 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
127 Participants
n=167 Participants
|
120 Participants
n=164 Participants
|
13 Participants
n=671 Participants
|
12 Participants
n=77 Participants
|
272 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
19 Participants
n=167 Participants
|
21 Participants
n=164 Participants
|
8 Participants
n=671 Participants
|
10 Participants
n=77 Participants
|
58 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
1 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
0 Participants
n=671 Participants
|
0 Participants
n=77 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Post dose on Day 1 up to Day 66 in Part 1Population: Included all participants in Part 1 who received at least 1 dose of study intervention (talazoparib or enzalutamide).
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per Common Terminology Criteria for Adverse Events (CTCAE) version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
Outcome measures
| Measure |
Part 2 Cohort 1: Placebo+Enzalutamide
n=6 Participants
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=13 Participants
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
Participants with TEAEs
|
6 Participants
|
13 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
Participants with medication error TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
Participants with serious TEAE
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
Participants with Maximum Grade 3 or 4 TEAE
|
1 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
Participants with Maximum Grade 5 TEAE
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Post dose on Day 1 up to Day 66 in Part 1Population: Included all participants in Part 1 who received at least 1 dose of study intervention (talazoparib or enzalutamide).
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1=mild AE; Grade 2=moderate AE; Grade 3=severe AE; Grade 4=life-threatening or disabling AE; Grade 5=death related to an AE. Medical Dictionary for Regulatory Activities (MedDRA) v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. Results as of 16 Aug 2022 are reported.
Outcome measures
| Measure |
Part 2 Cohort 1: Placebo+Enzalutamide
n=6 Participants
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=13 Participants
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
|---|---|---|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Grade 2 Anemia
|
0 Participants
|
2 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Grade 3 Anemia
|
1 Participants
|
6 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Grade 1 Neutropenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Grade 2 Neutropenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Grade 3 Neutropenia
|
0 Participants
|
4 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Grade 2 Leukopenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Grade 3 Leukopenia
|
0 Participants
|
3 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Grade 3 Thrombocytopenia
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)Population: Included all participants in Part 1 who received at least 1 dose of study intervention (talazoparib or enzalutamide).
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
Outcome measures
| Measure |
Part 2 Cohort 1: Placebo+Enzalutamide
n=6 Participants
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=13 Participants
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
|---|---|---|
|
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
Participants with TEAEs
|
6 Participants
|
13 Participants
|
|
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
Participants with medication error TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
Participants with serious TEAE
|
3 Participants
|
6 Participants
|
|
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
Participants with Maximum Grade 3 or 4 TEAE
|
6 Participants
|
11 Participants
|
|
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
Participants with Maximum Grade 5 TEAE
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)Population: Included all participants in Part 1 who received at least 1 dose of study intervention (talazoparib or enzalutamide).
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
Outcome measures
| Measure |
Part 2 Cohort 1: Placebo+Enzalutamide
n=6 Participants
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=13 Participants
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
|---|---|---|
|
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
Participants with TEAEs
|
6 Participants
|
13 Participants
|
|
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
Participants with medication error TEAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
Participants with serious TEAE
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
Participants with Maximum Grade 3 or 4 TEAE
|
4 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
Participants with Maximum Grade 5 TEAE
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)Population: Included all participants in Part 1 who received at least 1 dose of study intervention (talazoparib or enzalutamide).
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1=mild AE; Grade 2=moderate AE; Grade 3=severe AE; Grade 4=life-threatening or disabling AE; Grade 5=death related to an AE. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. Results as of 16 Aug 2022 are reported.
Outcome measures
| Measure |
Part 2 Cohort 1: Placebo+Enzalutamide
n=6 Participants
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=13 Participants
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
|---|---|---|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 1 Neutropenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 2 Neutropenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 3 Neutropenia
|
0 Participants
|
6 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 3 Leukopenia
|
0 Participants
|
5 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 3 Thrombocytopenia
|
0 Participants
|
3 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 4 Anemia
|
1 Participants
|
0 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 2 Lymphopenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 3 Lymphopenia
|
0 Participants
|
2 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 3 Anemia
|
3 Participants
|
10 Participants
|
|
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Grade 2 Leukopenia
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)Population: Included all participants in Part 1 who received at least 1 dose of study intervention (talazoparib or enzalutamide).
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are newly occurring AEs or those worsening after first dose. Treatment-related AE was any AE attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling; Grade 5=death related to an AE. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with incidence in \>=10% of participants are reported. Results as of 16 Aug 2022 are reported.
Outcome measures
| Measure |
Part 2 Cohort 1: Placebo+Enzalutamide
n=6 Participants
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=13 Participants
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
|---|---|---|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 3 Anemia
|
3 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 1 Neutropenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 2 Neutropenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 3 Neutropenia
|
0 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 2 Leukopenia
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 3 Leukopenia
|
0 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 4 Anemia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 2 Lymphopenia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 3 Thrombocytopenia
|
0 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Grade 3 Lymphopenia
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)Population: Included all participants randomized to double-blind study treatment in Part 2 Cohort 1 regardless of whether or not treatment was administered.
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by computed tomography (CT) of chest and CT or magnetic resonance imaging (MRI) of abdomen and pelvis. Progression is defined using RECIST 1.1 as a \>=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Results as of 16 Aug 2022 are reported for this outcome measure.
Outcome measures
| Measure |
Part 2 Cohort 1: Placebo+Enzalutamide
n=403 Participants
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=402 Participants
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
|---|---|---|
|
Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1
|
21.9 Months
Interval 16.6 to 25.1
|
NA Months
Interval 27.5 to
NA indicates not estimated due to less than half of participants meeting the criterion as of data cutoff date (16 Aug 2022).
|
PRIMARY outcome
Timeframe: From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)Population: Included DDR-deficient participants randomized to double-blind study treatment in Part 2 regardless of whether or not treatment was administered.
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by CT of chest and CT or MRI of abdomen and pelvis. Results as of 03 Oct 2022 are reported for this outcome measure.
Outcome measures
| Measure |
Part 2 Cohort 1: Placebo+Enzalutamide
n=199 Participants
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
|
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=200 Participants
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
|
|---|---|---|
|
BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2
|
13.8 Months
Interval 11.0 to 16.7
|
NA Months
Interval 21.9 to
NA indicates not estimated due to less than half of participants meeting the criterion as of data cutoff date (03 Oct 2022).
|
Adverse Events
Part 1: Talazoparib 1 mg QD+Enzalutamide
Part 1: Talazoparib 0.5 mg QD+Enzalutamide
Part 2 Cohort 1: Talazoparib+Enzalutamide (All-comer)
Part 2 Cohort 1: Placebo+Enzalutamide (All-comer)
Part 2 Participants With DDR Deficiencies: Talazoparib+Enzalutamide
Part 2 Participants With DDR Deficiencies: Placebo+Enzalutamide
Serious adverse events
| Measure |
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=13 participants at risk
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022). All-cause mortality and adverse events are reported for participants who received at least 1 dose of study intervention.
|
Part 1: Talazoparib 0.5 mg QD+Enzalutamide
n=6 participants at risk
Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022). All-cause mortality and adverse events are reported for participants who received at least 1 dose of study intervention.
|
Part 2 Cohort 1: Talazoparib+Enzalutamide (All-comer)
n=398 participants at risk
Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022). All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.
|
Part 2 Cohort 1: Placebo+Enzalutamide (All-comer)
n=401 participants at risk
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022). All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.
|
Part 2 Participants With DDR Deficiencies: Talazoparib+Enzalutamide
n=198 participants at risk
Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022). Participants who were DDR-deficient and received talazoparib+enzalutamide in Part 2 Cohort 1 were combined with participants enrolled in Part 2 Cohort 2 and included in the analysis for Part 2 Participants With DDR Deficiencies. All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.
|
Part 2 Participants With DDR Deficiencies: Placebo+Enzalutamide
n=199 participants at risk
Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022). Participants who were DDR-deficient and received placebo+enzalutamide in Part 2 Cohort 1 were combined with participants enrolled in Part 2 Cohort 2 and included in the analysis for Part 2 Participants With DDR Deficiencies. All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
13.8%
55/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
8.6%
17/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Cardiac failure
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Diverticulitis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Infectious pleural effusion
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Pneumonia necrotising
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Confusional state
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.3%
5/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Eye disorders
Retinal exudates
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Disease progression
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.2%
5/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Death
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Chest pain
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Asthenia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Gait disturbance
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
General physical health deterioration
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.3%
9/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Sepsis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Cystitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Infection
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Meningitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Septic shock
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Urethral stricture postoperative
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.2%
5/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Platelet count decreased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Blood culture positive
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Transaminases increased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sweat gland tumour
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Malignant spinal cord compression
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Seizure
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
10/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.2%
5/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Bladder stenosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Urinary bladder rupture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
COVID infection with complications
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Abscess
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
Other adverse events
| Measure |
Part 1: Talazoparib 1 mg QD+Enzalutamide
n=13 participants at risk
Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022). All-cause mortality and adverse events are reported for participants who received at least 1 dose of study intervention.
|
Part 1: Talazoparib 0.5 mg QD+Enzalutamide
n=6 participants at risk
Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022). All-cause mortality and adverse events are reported for participants who received at least 1 dose of study intervention.
|
Part 2 Cohort 1: Talazoparib+Enzalutamide (All-comer)
n=398 participants at risk
Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022). All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.
|
Part 2 Cohort 1: Placebo+Enzalutamide (All-comer)
n=401 participants at risk
Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022). All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.
|
Part 2 Participants With DDR Deficiencies: Talazoparib+Enzalutamide
n=198 participants at risk
Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022). Participants who were DDR-deficient and received talazoparib+enzalutamide in Part 2 Cohort 1 were combined with participants enrolled in Part 2 Cohort 2 and included in the analysis for Part 2 Participants With DDR Deficiencies. All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.
|
Part 2 Participants With DDR Deficiencies: Placebo+Enzalutamide
n=199 participants at risk
Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022). Participants who were DDR-deficient and received placebo+enzalutamide in Part 2 Cohort 1 were combined with participants enrolled in Part 2 Cohort 2 and included in the analysis for Part 2 Participants With DDR Deficiencies. All-cause mortality are reported for participants who were randomly assigned to double-blind study treatment in Part 2 regardless of whether or not treatment was administered. Adverse events are reported for participants who received at least 1 dose of study treatment in Part 2 and was based on the actual treatment received.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
76.9%
10/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
66.7%
4/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
64.8%
258/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
17.5%
70/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
64.1%
127/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
15.1%
30/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Neutrophil count decreased
|
61.5%
8/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
35.7%
142/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.0%
28/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
32.3%
64/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.5%
13/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Fatigue
|
38.5%
5/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
83.3%
5/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
33.7%
134/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
29.4%
118/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
33.3%
66/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
26.6%
53/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Platelet count decreased
|
23.1%
3/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
24.6%
98/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
14/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
24.7%
49/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
8/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Sinus bradycardia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Bundle branch block right
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Cardiac disorders
Cardiac failure congestive
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Eye disorders
Cataract
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Eye disorders
Extraocular muscle disorder
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Eye disorders
Visual impairment
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Nausea
|
53.8%
7/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
33.3%
2/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
20.4%
81/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
12.5%
50/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
20.2%
40/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
17.1%
34/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
50.0%
3/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
14.3%
57/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
13.7%
55/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
12.1%
24/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
11.1%
22/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Vomiting
|
38.5%
5/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.0%
28/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.5%
22/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.6%
15/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.0%
10/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
18.1%
72/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
17.0%
68/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
13.1%
26/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.1%
32/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.8%
15/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.7%
15/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.1%
10/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
6/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
12/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.2%
9/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
6/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Anal fissure
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.3%
17/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.7%
19/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
7/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.8%
7/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.8%
15/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Chest discomfort
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Influenza like illness
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
50.0%
3/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.3%
5/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
10/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
12/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.7%
11/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Oedema peripheral
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
10.6%
42/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.0%
24/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.1%
14/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.0%
12/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Peripheral swelling
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Pyrexia
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.0%
28/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
12/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
9.1%
18/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Asthenia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
14.1%
56/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
9.5%
38/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
15.2%
30/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
14.6%
29/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
General disorders
Malaise
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.3%
25/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
12/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Immune system disorders
Hypersensitivity
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Bronchitis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.5%
18/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
10/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.1%
10/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.0%
10/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Candida infection
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Furuncle
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Gingivitis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Hordeolum
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.5%
18/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.7%
11/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
6/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Otitis media
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
33.3%
2/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
10/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.2%
5/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.3%
5/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.5%
22/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.7%
19/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.0%
8/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.5%
11/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
33.3%
2/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Fall
|
30.8%
4/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
50.0%
3/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
17.1%
68/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
14.5%
58/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
12.1%
24/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
12.1%
24/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.5%
30/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.7%
15/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.1%
12/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
12/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.7%
19/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.5%
9/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.8%
11/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.2%
21/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
6/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.2%
13/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Blood pressure increased
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Lymphocyte count decreased
|
23.1%
3/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
11.3%
45/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.0%
20/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.1%
14/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.0%
12/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Weight decreased
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
10.1%
40/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
8.2%
33/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
9.1%
18/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
8.5%
17/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Weight increased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
8/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
White blood cell count decreased
|
46.2%
6/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
22.1%
88/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.5%
18/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
18.7%
37/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.5%
15/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.8%
23/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
8/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.1%
12/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.0%
16/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
12/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.6%
13/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.0%
8/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
53.8%
7/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
50.0%
3/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
21.6%
86/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
15.7%
63/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
20.2%
40/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
14.1%
28/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.8%
7/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.2%
5/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Gout
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.8%
7/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.7%
11/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.0%
20/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.2%
21/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.1%
12/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.0%
10/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.3%
17/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.7%
7/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
38.5%
5/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
14.6%
58/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
19.7%
79/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
12.6%
25/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
22.1%
44/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.8%
4/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
21.9%
87/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
17.7%
71/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
19.7%
39/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
21.6%
43/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.3%
25/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.0%
24/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.1%
10/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.5%
13/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.3%
5/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
8/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Jaw disorder
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.3%
9/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.0%
8/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.8%
19/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.7%
15/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
6/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.0%
8/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.0%
24/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.0%
24/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.5%
9/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.5%
13/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.8%
11/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.2%
13/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
7/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
8.8%
35/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
8.5%
34/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.1%
10/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.5%
15/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Aphasia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Disturbance in attention
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Dizziness
|
30.8%
4/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
12.1%
48/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.0%
24/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
10.1%
20/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.5%
15/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Dysarthria
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Dysgeusia
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.5%
26/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.7%
15/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
8.6%
17/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
7/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Encephalopathy
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Headache
|
38.5%
5/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
9.0%
36/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
9.2%
37/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.1%
12/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
11.1%
22/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Hypersomnia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
8/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.7%
7/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
7/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Lethargy
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.7%
7/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Memory impairment
|
30.8%
4/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.3%
13/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
14/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
7/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
7/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Neuralgia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Paraesthesia
|
23.1%
3/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
12/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
10/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
6/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.0%
8/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Sciatica
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.7%
7/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Spinal cord oedema
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Taste disorder
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.8%
7/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.2%
5/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Anxiety
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.2%
9/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.0%
8/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Confusional state
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Depressed mood
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Depression
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.8%
15/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.2%
9/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
7/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Mood swings
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Restlessness
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Sleep disorder
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.3%
29/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.0%
24/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
8.1%
16/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.5%
13/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Calculus bladder
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Haematuria
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
14/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.7%
31/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.1%
10/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.0%
14/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Hydronephrosis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.8%
7/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Nephrolithiasis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Nocturia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.2%
9/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Pollakiuria
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.2%
13/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
6/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.2%
13/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.0%
8/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.3%
13/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.7%
7/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.0%
10/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
33.3%
2/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.3%
13/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.7%
11/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.5%
9/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
30.8%
4/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
10.1%
40/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
6.0%
24/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
8.6%
17/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.5%
11/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.3%
5/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.2%
5/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.0%
20/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
8/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.5%
7/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
6/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.2%
5/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.3%
5/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
10/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
8/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
8.3%
33/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
10/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
7.1%
14/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.0%
4/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.3%
13/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.2%
9/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
6/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.8%
15/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
3.0%
12/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.5%
3/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
4.5%
9/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
4/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.3%
5/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.75%
3/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.8%
7/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.2%
9/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.0%
2/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
5.5%
11/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
2/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Embolism venous
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.25%
1/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.51%
1/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Hot flush
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
16.7%
1/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
11.8%
47/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
13.5%
54/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
11.6%
23/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
14.1%
28/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
13.8%
55/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
15.2%
61/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
18.2%
36/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
19.1%
38/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
|
Vascular disorders
Hypotension
|
15.4%
2/13 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.00%
0/6 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
10/398 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
1.00%
4/401 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
2.5%
5/198 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
0.50%
1/199 • Post first dose of any study intervention through 28 days after the last dose of study intervention (up to a maximum of 236 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. DDR-deficient participants included in both the analysis for Part 2 Cohorts 1 and 2 were counted in both cohorts.
|
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