Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer (NCT NCT03800836)

Last Updated: 2024-10-30

Results Overview

Objective Response Rate: percentage participants with confirmed complete response (CR) or partial response (PR) on 2 consecutive occasions \>or= 4 weeks apart, as determined by investigator according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Percentages have been rounded off. No participants were enrolled in cohort 4, hence no data reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

139 participants

Primary outcome timeframe

From screening up to approximately 43.6 months

Results posted on

2024-10-30

Participant Flow

Participants took part in this study from 13 February 2018 to 16 March 2022.

139 participants were enrolled, 2 were not treated and excluded from analyses. 137 participants were enrolled in either Cohort 1 (Arms A \[A1,2,3\], B \[B1,2\], C \[C1,2\], and D \[D1,2\]), Cohort 2 (Arm E) or Arm F1 in Cohort 3. Sponsor made decision not to continue study enrollment before arms F2, G1, G2 (Cohort 3) and H (Cohort 4) enrolled any participants.

Participant milestones

Participant milestones
Measure	Cohort 1-Arm A Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.
Overall Study STARTED	71	20	13	12	17	6
Overall Study Safety Population	70	20	12	12	17	6
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	71	20	13	12	17	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1-Arm A Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.
Overall Study Other	2	1	0	2	0	1
Overall Study Lost to Follow-up	2	0	1	1	3	0
Overall Study Withdrawal by Subject	1	0	0	0	0	0
Overall Study Physician Decision	31	3	6	4	4	5
Overall Study Death	34	16	5	5	10	0
Overall Study Symptomatic Deterioration	1	0	1	0	0	0

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1-Arm A n=70 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=20 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E n=17 Participants Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F n=6 Participants Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Total n=137 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 13.0 • n=5 Participants	50.2 years STANDARD_DEVIATION 9.6 • n=7 Participants	46.4 years STANDARD_DEVIATION 14.0 • n=5 Participants	48.8 years STANDARD_DEVIATION 9.6 • n=4 Participants	52.1 years STANDARD_DEVIATION 11.2 • n=21 Participants	53.2 years STANDARD_DEVIATION 7.4 • n=10 Participants	53.4 years STANDARD_DEVIATION 12.3 • n=115 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	20 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	17 Participants n=21 Participants	6 Participants n=10 Participants	137 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	15 Participants n=7 Participants	11 Participants n=5 Participants	9 Participants n=4 Participants	17 Participants n=21 Participants	6 Participants n=10 Participants	113 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	16 Participants n=115 Participants
Race/Ethnicity, Customized Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=10 Participants	18 Participants n=115 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	51 Participants n=5 Participants	14 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	11 Participants n=21 Participants	4 Participants n=10 Participants	100 Participants n=115 Participants
Race/Ethnicity, Customized Not Stated	7 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	12 Participants n=115 Participants
Race/Ethnicity, Customized Unknown	5 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	7 Participants n=115 Participants

PRIMARY outcome

Timeframe: From screening up to approximately 43.6 months

Population: Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation. Participants without a postbaseline tumor assessment were considered as non-responders.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=70 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=20 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1 and Cohort 4: Percentage of Participants With Objective Response (OR) as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST), Version (v) 1.1	51.4 percentage of participants Interval 39.17 to 63.56	65.0 percentage of participants Interval 40.78 to 84.61	66.7 percentage of participants Interval 34.89 to 90.08	33.3 percentage of participants Interval 9.92 to 65.11	—	—	—	—	—

PRIMARY outcome

Timeframe: 2-6 weeks following last dose of study treatment (up to 69 weeks)

Population: Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation.

pCR rate was defined as the percentage of participants who had no residual invasive disease in the breast and no residual disease in the lymph nodes (ypT0/Tis ypN0 in the current American Joint Committee on Cancer (AJCC )staging system) based on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant therapy.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=6 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 3: Pathological Complete Response (pCR) Rate	50 percentage of participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month)

Population: Safety population included all participants who received any study treatment.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any new disease or worsening of an existing disease are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0). No participants were enrolled in cohort 3 Arm G and 4, and hence no data was reported.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=70 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=20 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E n=17 Participants Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F n=6 Participants Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1, Cohort 2, Cohort 3 and Cohort 4: Number of Participants With Adverse Events (AEs)	70 Participants	20 Participants	12 Participants	12 Participants	17 Participants	6 Participants	—	—	—

SECONDARY outcome

Timeframe: From the date of first documented confirmed response (CR or PR) to disease progression or death due to any cause (up to approximately 43.6 months)

Population: Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation. Number analyzed are participants who had OR (i.e., a confirmed CR or PR).

DOR was defined as the time from the first occurrence of a documented confirmed CR or PR to the first date of recorded disease progression (PD), as determined by the investigator according to RECIST v1.1 or death from any cause. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduced in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameter of target lesions, taking as reference the smallest sum on study (nadir) including baseline; the appearance of one or more new lesions. No participants were enrolled in cohort 4, and hence no data was reported. Participants who did not progress or died at time of analysis were censored at last disease assessment date.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=36 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=13 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=8 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=4 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1 and Cohort 4: Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1	7.8 months Interval 5.6 to 12.9	7.3 months Interval 5.0 to 9.2	9.2 months Interval 3.9 to 14.7	4.8 months Interval 3.7 to The median and upper limit of confidence interval (CI) were not estimable due to less number of participants with events.	—	—	—	—	—

SECONDARY outcome

Timeframe: From enrollment up to disease progression or death due to any cause whichever occurs first (up to approximately 43.6 months)

Population: Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation.

PFS: time from enrollment to date of 1st recorded occurrence of PD, as determined by investigator according to RECIST v1.1 or death from any cause, whichever occurs first. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (nadir) including baseline; appearance of one or more new lesions. Data for participants who did not experience PD or death was censored at last date of evaluable tumor assessment. No participants were enrolled in cohort 4, and hence no data was reported.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=70 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=20 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1 and Cohort 4: Progression-Free Survival (PFS), as Assessed by Investigator Based on RECIST v1.1	7.2 months Interval 5.3 to 7.4	6.6 months Interval 3.4 to 9.2	8.8 months Interval 5.6 to 12.9	6.5 months Interval 5.2 to 11.3	—	—	—	—	—

SECONDARY outcome

Timeframe: From enrollment up to death due to any cause (up to approximately 43.6 months).

Population: Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation.

OS was defined as the time from enrollment to death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=70 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=20 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1 and Cohort 4: Overall Survival (OS)	28.3 months Interval 17.2 to 43.0	20.1 months Interval 11.1 to 30.8	NA months Interval 21.2 to The median and upper limit of confidence interval (CI) were not estimable due to less number of participants with events.	NA months Interval 11.7 to The median and upper limit of CI were not estimable due to less number of participants with events.	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 15 Cycle 1: pre-dose and 1, 2, 4 and 6 hours post-dose, Day 15 Cycle2: predose and 1, 2, 4 and 6 hours post-dose and Day 15 Cycle 3 - post dose up to - 3 hours (each cycle is of 28 days)

Population: Pharmacokinetic (PK) evaluable population included all participants who had at least 1 evaluable PK concentration post ipatasertib administration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given time point.

Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=6 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=14 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=50 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=6 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E n=14 Participants Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F n=6 Participants Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 n=6 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 n=6 Participants Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 n=6 Participants Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 1 Day 15 4 hour Post-dose	226 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 32.7	255 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 39.7	305 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 40.8	225 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 10.0	266 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 78.1	—	—	—	—
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 1 Day 15 6 hour Post-dose	—	182 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 39.2	233 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 46.7	165 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 25.0	186 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 80.3	—	—	—	—
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 2 Day 15 Pre-dose	—	—	—	—	—	44.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 43.3	50.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 31.4	29.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 59.5	31.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 53.1
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 1 Day 15 Pre-dose	47.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 47.2	13.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 783.4	29.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 163.1	30.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 37.1	46.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 172.8	61.1 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 94.3	77.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 207.0	—	—
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 1 Day 15 1 hour Post-dose	507 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 43.6	182 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 167.0	258 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 127.2	253 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 128.0	219 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 186.6	—	—	—	—
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 1 Day 15 2 hour Post-dose	318 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 21.4	318 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 47.8	421 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 51.5	287 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 35.7	282 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 235.6	—	—	225 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.9	190 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 484.7
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 2 Day 15 1 hour Post-dose	—	—	—	—	—	260 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 21.6	614 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 34.2	232 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 150.0	364 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 81.4
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 2 Day 15 2 hour Post-dose	—	—	—	—	—	575 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 22.5	500 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 18.3	311 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 67.5	610 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 36.7
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 2 Day 15 4 hour Post-dose	—	—	—	—	—	402 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 44.9	340 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 29.9	258 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 20.6	433 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.7
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 2 Day 15 6 hour Post-dose	—	—	—	—	—	253 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 31.7	273 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 15.3	162 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 8.2	234 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 32.6
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Cycle 3 Day 15 1 to 3 hour Post-dose	—	126 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 241.7	196 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 133.7	134 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 82.8	214 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 130.8	127 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 369.0	155 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 282.3	233 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 120.9	382 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 87.9

SECONDARY outcome

Timeframe: Day 15 Cycle 1 - pre-dose and 1 hour, 2 hours, 4 hours and 6 hours post-dose, Day 15 Cycle2: predose and 1 hour, 2 hours, 4 hours and 6 hours post-dose and Day 15 Cycle 3 - post dose up to - 3 hours (each cycle is of 28 days)

Population: PK evaluable population included all participants who had at least 1 evaluable PK concentration post ipatasertib administration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given time point.

Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=6 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=14 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=50 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=6 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E n=14 Participants Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F n=6 Participants Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 n=6 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 n=6 Participants Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 n=6 Participants Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 1 Day 15 6 hour Post-dose	—	106 ng/mL Geometric Coefficient of Variation 47.3	133 ng/mL Geometric Coefficient of Variation 60.3	120 ng/mL Geometric Coefficient of Variation 45.6	101 ng/mL Geometric Coefficient of Variation 82.8	—	—	—	—
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 2 Day 15 Pre-dose	—	—	—	—	—	22.5 ng/mL Geometric Coefficient of Variation 27.6	20.5 ng/mL Geometric Coefficient of Variation 38.4	15.2 ng/mL Geometric Coefficient of Variation 81.4	24.4 ng/mL Geometric Coefficient of Variation 76.7
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 3 Day 15 1 to 3 hour Posst-dose	—	47.1 ng/mL Geometric Coefficient of Variation 238.3	69.4 ng/mL Geometric Coefficient of Variation 161.2	68.6 ng/mL Geometric Coefficient of Variation 131.8	79.4 ng/mL Geometric Coefficient of Variation 150.8	50.4 ng/mL Geometric Coefficient of Variation 299.8	45.0 ng/mL Geometric Coefficient of Variation 182.3	84.6 ng/mL Geometric Coefficient of Variation 227.5	144 ng/mL Geometric Coefficient of Variation 121.6
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 1 Day 15 Pre-dose	27.0 ng/mL Geometric Coefficient of Variation 32.4	8.27 ng/mL Geometric Coefficient of Variation 404.3	15.0 ng/mL Geometric Coefficient of Variation 165.9	23.3 ng/mL Geometric Coefficient of Variation 58.3	24.1 ng/mL Geometric Coefficient of Variation 97.7	30.9 ng/mL Geometric Coefficient of Variation 48.3	36.4 ng/mL Geometric Coefficient of Variation 356.1	—	—
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 1 Day 15 1 hour Post-dose	200 ng/mL Geometric Coefficient of Variation 58.3	61.8 ng/mL Geometric Coefficient of Variation 209.2	85.9 ng/mL Geometric Coefficient of Variation 119.9	126 ng/mL Geometric Coefficient of Variation 158.4	86.4 ng/mL Geometric Coefficient of Variation 135.3	—	—	—	—
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 1 Day 15 2 hour Post-dose	151 ng/mL Geometric Coefficient of Variation 29.9	124 ng/mL Geometric Coefficient of Variation 55.0	153 ng/mL Geometric Coefficient of Variation 68.8	166 ng/mL Geometric Coefficient of Variation 102.2	120 ng/mL Geometric Coefficient of Variation 193.0	—	—	78.1 ng/mL Geometric Coefficient of Variation 125.6	177 ng/mL Geometric Coefficient of Variation 37.1
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 1 Day 15 4 hour Post-dose	118 ng/mL Geometric Coefficient of Variation 26.1	121 ng/mL Geometric Coefficient of Variation 41.5	157 ng/mL Geometric Coefficient of Variation 62.9	154 ng/mL Geometric Coefficient of Variation 39.8	134 ng/mL Geometric Coefficient of Variation 99.2	—	—	—	—
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 2 Day 15 1 hour Post-dose	—	—	—	—	—	41.3 ng/mL Geometric Coefficient of Variation 90.1	148 ng/mL Geometric Coefficient of Variation 39.4	70.5 ng/mL Geometric Coefficient of Variation 244.4	140 ng/mL Geometric Coefficient of Variation 94.2
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 2 Day 15 2 hour Post-dose	—	—	—	—	—	206 ng/mL Geometric Coefficient of Variation 35.1	184 ng/mL Geometric Coefficient of Variation 28.0	120 ng/mL Geometric Coefficient of Variation 171.0	355 ng/mL Geometric Coefficient of Variation 22.9
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 2 Day 15 4 hour Post-dose	—	—	—	—	—	185 ng/mL Geometric Coefficient of Variation 30.2	146 ng/mL Geometric Coefficient of Variation 46.5	131 ng/mL Geometric Coefficient of Variation 30.8	402 ng/mL Geometric Coefficient of Variation 43.4
Cohort 1 and Cohort 4: Plasma Concentration of Ipatasertib Metabolite M1 (G-037720) Cycle 2 Day 15 6 hour Post-dose	—	—	—	—	—	124 ng/mL Geometric Coefficient of Variation 11.4	137 ng/mL Geometric Coefficient of Variation 30.4	98.8 ng/mL Geometric Coefficient of Variation 77.3	232 ng/mL Geometric Coefficient of Variation 57.4

SECONDARY outcome

Timeframe: From baseline up to 30 days from the last dose of atezolizumab (to approximately 4 years 1.1 month)

Population: Immunogenicity evaluable population included all participants with atleast 1 ADA assessment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given time point.

Participants were considered to be ADA positive if they were ADA negative or were missing data at Baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at Baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the Baseline sample (treatment-enhanced ADA response). Participants were considered to be ADA negative if they were ADA negative or had missing data at Baseline and all postbaseline samples were negative, or if they were ADA positive at Baseline but did not have any postbaseline samples with a titer that was at least 0.60 titer unit greater than the titer of the baseline sample (treatment unaffected). Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=6 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=13 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=43 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=6 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E n=14 Participants Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F n=6 Participants Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 n=6 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 n=6 Participants Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 n=6 Participants Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1 and Cohort 4: Number of Participants With Anti-Drug Antibodies (ADAs) for Atezolizumab During Study Treatment Baseline: Positive for ADA	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1 and Cohort 4: Number of Participants With Anti-Drug Antibodies (ADAs) for Atezolizumab During Study Treatment Baseline: Negative for ADA	6 Participants	13 Participants	43 Participants	6 Participants	14 Participants	0 Participants	0 Participants	6 Participants	6 Participants
Cohort 1 and Cohort 4: Number of Participants With Anti-Drug Antibodies (ADAs) for Atezolizumab During Study Treatment Post Baseline: Positive for Treatment Emergent ADA	0 Participants	3 Participants	2 Participants	0 Participants	3 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Cohort 1 and Cohort 4: Number of Participants With Anti-Drug Antibodies (ADAs) for Atezolizumab During Study Treatment Post Baseline: Negative for Treatment Emergent ADA	6 Participants	10 Participants	38 Participants	6 Participants	9 Participants	4 Participants	5 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and 15: predose and 30 mins post dose; Cycle 2: Day 1 and 15 predose, Cycle 3, 4, 8, 12, and 16 Day 1: predose; treatment discontinuation visit

Population: PK evaluable population included all participants who had at least 1 evaluable PK concentration post atezolizumab administration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given time point.

Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=6 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=14 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=50 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=6 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E n=14 Participants Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F n=6 Participants Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 n=6 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 n=6 Participants Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 n=6 Participants Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 12 Day 1 Pre-Dose	333000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	505000 ng/mL Geometric Coefficient of Variation 14.4	—	—	285000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	122000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	384000 ng/mL Geometric Coefficient of Variation 11.8	393000 ng/mL Geometric Coefficient of Variation 26	—
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Treatment Discontinuation	—	97400 ng/mL Geometric Coefficient of Variation 153.2	135000 ng/mL Geometric Coefficient of Variation 99.8	253000 ng/mL Geometric Coefficient of Variation 81.9	195000 ng/mL Geometric Coefficient of Variation 47.5	337000 ng/mL Geometric Coefficient of Variation 31.7	181000 ng/mL Geometric Coefficient of Variation 40.9	274000 ng/mL Geometric Coefficient of Variation 113	178000 ng/mL Geometric Coefficient of Variation 67.9
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 1 Day 1 Pre-dose	—	—	853 ng/mL Geometric Coefficient of Variation 1344.8	—	65.3 ng/mL Geometric Coefficient of Variation 3.4	—	—	82.5 ng/mL Geometric Coefficient of Variation 7.6	—
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 1 Day 1 30 min Post-dose	354000 ng/mL Geometric Coefficient of Variation 12.2	330000 ng/mL Geometric Coefficient of Variation 18.1	329000 ng/mL Geometric Coefficient of Variation 25.3	315000 ng/mL Geometric Coefficient of Variation 5.4	365000 ng/mL Geometric Coefficient of Variation 19.2	—	—	335000 ng/mL Geometric Coefficient of Variation 13.9	339000 ng/mL Geometric Coefficient of Variation 13.6
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 1 Day 15 Pre-Dose	106000 ng/mL Geometric Coefficient of Variation 12.1	75200 ng/mL Geometric Coefficient of Variation 170.2	94500 ng/mL Geometric Coefficient of Variation 27.8	93100 ng/mL Geometric Coefficient of Variation 15.6	91700 ng/mL Geometric Coefficient of Variation 21	126 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	87100 ng/mL Geometric Coefficient of Variation 31.6	108000 ng/mL Geometric Coefficient of Variation 32.2
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 1 Day 15 30 min Post-dose	—	—	351000 ng/mL Geometric Coefficient of Variation 49	—	393000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	362000 ng/mL Geometric Coefficient of Variation 8.8	370000 ng/mL Geometric Coefficient of Variation 9.8	274000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	345000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 2 Day 1 Pre-Dose	143000 ng/mL Geometric Coefficient of Variation 34.3	90200 ng/mL Geometric Coefficient of Variation 883.4	149000 ng/mL Geometric Coefficient of Variation 45	99700 ng/mL Geometric Coefficient of Variation 118.4	132000 ng/mL Geometric Coefficient of Variation 45	101000 ng/mL Geometric Coefficient of Variation 39.1	121000 ng/mL Geometric Coefficient of Variation 21.6	147000 ng/mL Geometric Coefficient of Variation 35.3	156000 ng/mL Geometric Coefficient of Variation 20
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 2 Day 15 Pre-Dose	—	—	120000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	180000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	124000 ng/mL Geometric Coefficient of Variation 83.8	189000 ng/mL Geometric Coefficient of Variation 18.2	178000 ng/mL Geometric Coefficient of Variation 41.7	194000 ng/mL Geometric Coefficient of Variation 26.1
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 3 Day 1 Pre-Dose	193000 ng/mL Geometric Coefficient of Variation 85.5	105000 ng/mL Geometric Coefficient of Variation 1195.9	216000 ng/mL Geometric Coefficient of Variation 50.7	219000 ng/mL Geometric Coefficient of Variation 32	246000 ng/mL Geometric Coefficient of Variation 33	166000 ng/mL Geometric Coefficient of Variation 34.7	230000 ng/mL Geometric Coefficient of Variation 16.1	197000 ng/mL Geometric Coefficient of Variation 32.4	247000 ng/mL Geometric Coefficient of Variation 9.7
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 4 Day 1 Pre-Dose	347000 ng/mL Geometric Coefficient of Variation 12.4	179000 ng/mL Geometric Coefficient of Variation 256.2	283000 ng/mL Geometric Coefficient of Variation 23.8	239000 ng/mL Geometric Coefficient of Variation 37	283000 ng/mL Geometric Coefficient of Variation 16.7	293000 ng/mL Geometric Coefficient of Variation 40.3	293000 ng/mL Geometric Coefficient of Variation 18.3	250000 ng/mL Geometric Coefficient of Variation 43.9	247000 ng/mL Geometric Coefficient of Variation 46
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 8 Day 1 Pre-Dose	376000 ng/mL Geometric Coefficient of Variation 11.9	398000 ng/mL Geometric Coefficient of Variation 34.4	345000 ng/mL Geometric Coefficient of Variation 55.9	385000 ng/mL Geometric Coefficient of Variation 19.2	293000 ng/mL Geometric Coefficient of Variation 7.1	386000 ng/mL Geometric Coefficient of Variation 32.5	545000 ng/mL Geometric Coefficient of Variation 29.6	153000 ng/mL Geometric Coefficient of Variation 119.9	357000 ng/mL Geometric Coefficient of Variation 10.3
Cohort 1 and Cohort 4: Plasma Concentration of Atezolizumab Cycle 16 Day 1Pre-Dose	562000 ng/mL Geometric Coefficient of Variation 40.3	408000 ng/mL Geometric Coefficient of Variation 42	—	388000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	135000 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—

SECONDARY outcome

Timeframe: From screening up to confirmed SD or CR or PR (up to approximately 43.6 months)

Population: Efficacy evaluable population included all enrolled participants who received at least one dose of study treatment, regardless of treatment allocation.

CBR was defined as percentage of participants with stable disease (SD) for at least 24 weeks or with confirmed CR or PR as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Since, Cohort 4 did not enroll any participants, data is only reported for Cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1-Arm A n=70 Participants Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm B n=20 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm C n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1-Arm D n=12 Participants Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2-Arm E Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28-days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3-Arm F Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.	Cohort 1- Arm C2 Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 of Cycle 1 and 840 mg IV Atezo on Day 15 of Cycle 1 (1Cycle=28days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day cycle in the expansion stage C2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D1 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28-day Cycle during the safety run-in stage (D1) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D2 Participants with locally advanced or metastatic TNBC received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat on days 15-21 of cycle 1. In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on days 1 and 15 of each 28-day cycle in the expansion stage D2 until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.
Cohort 1 and Cohort 4: Clinical Benefit Rate (CBR) as Assessed by Investigator Based on RECIST v1.1	58.6 percentage of participants Interval 46.17 to 70.23	65.0 percentage of participants Interval 40.78 to 84.61	75.0 percentage of participants Interval 42.81 to 94.51	58.3 percentage of participants Interval 27.67 to 84.83	—	—	—	—	—

Adverse Events

Cohort 1- Arm A

Serious events: 26 serious events

Other events: 70 other events

Deaths: 34 deaths

Cohort 1- Arm B

Serious events: 9 serious events

Other events: 20 other events

Deaths: 16 deaths

Cohort 1- Arm C

Serious events: 5 serious events

Other events: 12 other events

Deaths: 5 deaths

Cohort 1- Arm D

Serious events: 4 serious events

Other events: 12 other events

Deaths: 5 deaths

Cohort 2- Arm E

Serious events: 5 serious events

Other events: 17 other events

Deaths: 10 deaths

Cohort 3- Arm F

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1- Arm A n=70 participants at risk Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm B n=20 participants at risk Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm C n=12 participants at risk Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D n=12 participants at risk Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2- Arm E n=17 participants at risk Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28 days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3- Arm F n=6 participants at risk Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.
General disorders Mucosal inflammation	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Blood and lymphatic system disorders Neutropenia	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Cardiac disorders Acute coronary syndrome	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Diplopia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Abdominal pain	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Colitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Diarrhoea	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Nausea	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Asthenia	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Chest pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders General physical health deterioration	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Pyrexia	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Hepatobiliary disorders Cholangitis acute	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Anal abscess	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Arthritis bacterial	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations COVID-19	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Cellulitis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Device related infection	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Endocarditis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Neutropenic sepsis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Pneumonia	5.7% 4/70 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Postoperative wound infection	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Pyelonephritis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Respiratory tract infection	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Sepsis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Skin infection	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Tuberculosis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Wound infection	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Alanine aminotransferase increased	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Transaminases increased	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Troponin I increased	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hyperamylasaemia	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Cerebrovascular accident	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Ischaemic stroke	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Presyncope	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Seizure	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Renal and urinary disorders Acute kidney injury	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Renal and urinary disorders Nephritis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.9% 2/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Rash	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Skin ulcer	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.

Other adverse events

Other adverse events
Measure	Cohort 1- Arm A n=70 participants at risk Participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who had not previously received chemotherapy in the advanced setting received 400 milligrams (mg) of ipatasertib (Ipat) orally, once daily (QD) on Days 1-21, 840 mg intravenous (IV) of atezolizumab (Atezo) on Days 1 and 15, and 80 milligrams per square meter (mg/m\^2) IV paclitaxel (Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (A1), subsequent expansion arms enrolled (A2 and A3). All participants in Arm A continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm B n=20 participants at risk Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 840 mg IV of Atezo on Days 1 and 15, and 100 mg/m\^2 IV nab-paclitaxel (Nab-Pac) on Days 1, 8, and 15 of each 28-day cycle. Following completion of a safety run-in cohort (B1), a subsequent expansion arm enrolled (B2). All participants in Arm B continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm C n=12 participants at risk Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 400 mg of Ipat orally, QD on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Day 15 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 840 mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, and 15 of each 28-day Cycle. Following completion of the safety run-in cohort (C1), a subsequent expansion cohort (C2) enrolled. All participants in Arm C continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 1- Arm D n=12 participants at risk Participants with locally advanced or metastatic TNBC who had not previously received chemotherapy in the advanced setting received 840 mg IV Atezo on Days 1 and 15, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 400 mg Ipat orally on days 15-21 of Cycle 1 (28 day cycle). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21, 80 mg/m2 IV Pac on Days 1, 8, and 15 and 840 mg IV Atezo on Days 1 and 15 of each 28 day Cycle. Following completion of the safety run-in cohort (D1), a subsequent expansion cohort (D2) enrolled. All participants in Arm D continued to receive treatment until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 2- Arm E n=17 participants at risk Participants in the second-line and third-line setting with locally advanced or metastatic TNBC received 400 mg Ipat orally QD on Days 1-28 and 840 mg IV Atezo on Days 8 and 22 of Cycle 1 (Cycle 1 = 35 days). In Cycles ≥ 2, participants received 400 mg Ipat orally on Days 1-21 and 840 mg IV Atezo on Days 1 and 15 of each cycle (Cycles ≥ 2 = 28 days) until loss of clinical benefit, unacceptable toxicity, withdrawal of consent, or end of the study.	Cohort 3- Arm F n=6 participants at risk Participants in the safety run-in stage (arm F1) with locally advanced T2-4 TNBC received 300 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15, 60 mg/m2 IV doxorubicin and 600 mg/m2 IV cyclophosphamide on Days 1 and 15 of Cycles 1 and 2 (1 Cycle=28-days). Participants then received 400 mg Ipat orally QD on Days 1-21, 840mg IV Atezo on Days 1 and 15 and 80 mg/m2 IV Pac on Days 1, 8, 15, and 22 of Cycles 3-5, until completion of 5 cycles or disease progression or unacceptable toxicity, whichever occurred first.
General disorders Oedema peripheral	7.1% 5/70 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Pain	7.1% 5/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Peripheral swelling	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Pyrexia	24.3% 17/70 • Number of events 26 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	30.0% 6/20 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	41.7% 5/12 • Number of events 12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	23.5% 4/17 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Conjunctivitis	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Cystitis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Sciatica	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Sensory disturbance	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Syncope	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Psychiatric disorders Anxiety	4.3% 3/70 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 4/12 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Psychiatric disorders Depressed mood	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Psychiatric disorders Euphoric mood	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Psychiatric disorders Insomnia	7.1% 5/70 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Renal and urinary disorders Acute kidney injury	1.4% 1/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Immune system disorders Hypersensitivity	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Renal and urinary disorders Dysuria	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Alveolar osteitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Bronchitis	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Renal and urinary disorders Renal failure	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Reproductive system and breast disorders Breast pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Cellulitis	1.4% 1/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Blood and lymphatic system disorders Anaemia	24.3% 17/70 • Number of events 20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	30.0% 6/20 • Number of events 10 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	66.7% 4/6 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Blood and lymphatic system disorders Neutropenia	21.4% 15/70 • Number of events 43 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	15.0% 3/20 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Ear and labyrinth disorders Vertigo	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Endocrine disorders Hyperthyroidism	7.1% 5/70 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Endocrine disorders Hypothyroidism	10.0% 7/70 • Number of events 8 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Conjunctivitis allergic	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Dry eye	8.6% 6/70 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Eyelid ptosis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Lacrimation increased	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Visual acuity reduced	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Xerophthalmia	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Abdominal pain	17.1% 12/70 • Number of events 15 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Abdominal pain upper	7.1% 5/70 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Anal fissure	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Colitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Constipation	35.7% 25/70 • Number of events 34 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	35.0% 7/20 • Number of events 8 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 4/12 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	41.7% 5/12 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	17.6% 3/17 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Diarrhoea	84.3% 59/70 • Number of events 127 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	75.0% 15/20 • Number of events 51 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	83.3% 10/12 • Number of events 22 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	75.0% 9/12 • Number of events 18 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	52.9% 9/17 • Number of events 14 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	100.0% 6/6 • Number of events 19 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Dry mouth	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Dyspepsia	14.3% 10/70 • Number of events 11 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	15.0% 3/20 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Gastritis	7.1% 5/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.7% 4/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Haemorrhoids	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	20.0% 4/20 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Large intestine polyp	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Mouth ulceration	2.9% 2/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Nausea	52.9% 37/70 • Number of events 55 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	80.0% 16/20 • Number of events 29 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 4/12 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	41.7% 5/12 • Number of events 10 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	29.4% 5/17 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	83.3% 5/6 • Number of events 9 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Stomatitis	11.4% 8/70 • Number of events 12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	15.0% 3/20 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Toothache	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Vomiting	21.4% 15/70 • Number of events 29 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	55.0% 11/20 • Number of events 19 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 4/12 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	17.6% 3/17 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Asthenia	27.1% 19/70 • Number of events 28 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	35.0% 7/20 • Number of events 12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 4/12 • Number of events 9 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	52.9% 9/17 • Number of events 10 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	50.0% 3/6 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Chest pain	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Chills	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Face oedema	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Fatigue	45.7% 32/70 • Number of events 46 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	30.0% 6/20 • Number of events 8 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	41.7% 5/12 • Number of events 9 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 4/12 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	11.8% 2/17 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Feeling hot	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders General physical health deterioration	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Influenza like illness	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Malaise	2.9% 2/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Mucosal inflammation	7.1% 5/70 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	11.8% 2/17 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Non-cardiac chest pain	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Folliculitis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Furuncle	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Gastroenteritis viral	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Genital herpes	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Herpes virus infection	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Herpes zoster	2.9% 2/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Hordeolum	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Influenza	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Lower respiratory tract infection	7.1% 5/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Mastitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Nasopharyngitis	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Oral candidiasis	4.3% 3/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Paronychia	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	20.0% 4/20 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Pharyngotonsillitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Pneumonia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Rash pustular	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Respiratory tract infection	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Rhinitis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Sinusitis	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Tonsillitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Tooth infection	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Upper respiratory tract infection	10.0% 7/70 • Number of events 9 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Urinary tract infection	11.4% 8/70 • Number of events 9 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Urinary tract infection bacterial	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Vascular access site infection	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Viral upper respiratory tract infection	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Accidental overdose	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Infusion related reaction	14.3% 10/70 • Number of events 15 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Procedural pain	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Vascular access site pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Alanine aminotransferase increased	20.0% 14/70 • Number of events 22 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Amylase increased	5.7% 4/70 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Aspartate aminotransferase increased	12.9% 9/70 • Number of events 13 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Blood alkaline phosphatase increased	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	11.8% 2/17 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Blood creatinine increased	2.9% 2/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Blood thyroid stimulating hormone increased	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Gamma-glutamyltransferase increased	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Lipase increased	4.3% 3/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Lymphocyte count decreased	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Neutrophil count decreased	4.3% 3/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Platelet count decreased	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Transaminases increased	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Weight decreased	7.1% 5/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Weight increased	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations White blood cell count decreased	2.9% 2/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	11.8% 2/17 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Decreased appetite	20.0% 14/70 • Number of events 17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	15.0% 3/20 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 4/12 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	17.6% 3/17 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Food intolerance	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hypercholesterolaemia	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hyperglycaemia	8.6% 6/70 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hypocalcaemia	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hypokalaemia	4.3% 3/70 • Number of events 8 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hypomagnesaemia	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Arthralgia	18.6% 13/70 • Number of events 15 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 4/12 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	17.6% 3/17 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Back pain	15.7% 11/70 • Number of events 14 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	20.0% 4/20 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.3% 3/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Myalgia	11.4% 8/70 • Number of events 9 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Neck pain	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 7/70 • Number of events 9 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Amnesia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Dizziness	8.6% 6/70 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	15.0% 3/20 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Dysaesthesia	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Dysgeusia	11.4% 8/70 • Number of events 9 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Headache	27.1% 19/70 • Number of events 29 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	20.0% 4/20 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	29.4% 5/17 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Hypoaesthesia	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Neuralgia	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Neuropathy peripheral	28.6% 20/70 • Number of events 24 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	45.0% 9/20 • Number of events 11 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	58.3% 7/12 • Number of events 8 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Neurotoxicity	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 2/6 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Paraesthesia	12.9% 9/70 • Number of events 9 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Peripheral sensory neuropathy	10.0% 7/70 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Presyncope	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Reproductive system and breast disorders Vulvovaginal inflammation	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Cough	18.6% 13/70 • Number of events 15 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	15.0% 3/20 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Dysphonia	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 10/70 • Number of events 11 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.6% 6/70 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	11.8% 2/17 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.4% 1/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	15.0% 3/20 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Alopecia	37.1% 26/70 • Number of events 27 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	55.0% 11/20 • Number of events 13 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	50.0% 6/12 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	58.3% 7/12 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	66.7% 4/6 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Dermatitis acneiform	7.1% 5/70 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Dry skin	8.6% 6/70 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Eczema	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Erythema	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Intertrigo	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Nail discolouration	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Nail dystrophy	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	50.0% 3/6 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Onychalgia	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Onycholysis	7.1% 5/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Papule	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Pruritus	15.7% 11/70 • Number of events 15 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	20.0% 4/20 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Rash	35.7% 25/70 • Number of events 39 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	40.0% 8/20 • Number of events 11 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	25.0% 3/12 • Number of events 14 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	33.3% 4/12 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	41.2% 7/17 • Number of events 7 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	50.0% 3/6 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 7/70 • Number of events 10 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Rash papular	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Rash pruritic	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Vascular disorders Deep vein thrombosis	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	10.0% 2/20 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Vascular disorders Hot flush	5.7% 4/70 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	15.0% 3/20 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Vascular disorders Hypertension	8.6% 6/70 • Number of events 6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Vascular disorders Lymphoedema	7.1% 5/70 • Number of events 5 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 2/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.9% 1/17 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Vascular disorders Raynaud's phenomenon	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	5.0% 1/20 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Vascular disorders Venous thrombosis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	16.7% 1/6 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Blepharitis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Ocular discomfort	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Papilloedema	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Eye disorders Vision blurred	4.3% 3/70 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Anal fistula	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Gastrointestinal disorders Proctitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
General disorders Swelling	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations COVID-19	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Gastroenteritis	4.3% 3/70 • Number of events 4 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Gingivitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Impetigo	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Onychomycosis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Pharyngitis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Respiratory tract infection viral	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Viral infection	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Vulvovaginal candidiasis	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Infections and infestations Wound infection	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Animal bite	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Animal scratch	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Injury, poisoning and procedural complications Seroma	1.4% 1/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Blood cholesterol increased	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Blood creatinine decreased	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Blood triglycerides increased	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Cortisol decreased	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Investigations Haemoglobin decreased	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hypertriglyceridaemia	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Metabolism and nutrition disorders Hyponatraemia	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Dysarthria	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Memory impairment	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Nervous system disorders Retinal migraine	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Psychiatric disorders Depression	2.9% 2/70 • Number of events 2 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Renal and urinary disorders Urinary incontinence	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Reproductive system and breast disorders Vulvovaginal burning sensation	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Lung opacity	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Erythema annulare	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Skin and subcutaneous tissue disorders Skin exfoliation	1.4% 1/70 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Vascular disorders Flushing	4.3% 3/70 • Number of events 3 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.
Vascular disorders Thrombosis	0.00% 0/70 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/20 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/12 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	8.3% 1/12 • Number of events 1 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/17 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.	0.00% 0/6 • Up until 90 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first (up to 4 years 1 month) Safety population included all participants who received any study treatment. No participants enrolled in Arm G and H, and hence no data was reported.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER